6026. Beauti-vator massage device. (F.D.C. No. 43033. S. No. 52-250 P.) QUANTITY: 102 individually cartoned devices at Minneapolis, Minn. SHIPPED: 4-24-59 and 5-1-59, from St. Louis, Mo., by Beauti-vator Sales Co. LABEL IN PART: (Ctn.) "Beauti-vator By Posturamic Systems, Inc., St. Louis 15 Mo. Trims Facial Contours-Tones Facial Muscles-Beautifies Complexion-Gives Relaxing Massage," (device) "Beauti-Vator By Posturamic Systems, Inc. 533 Bittner St. St. Louis 15, Mo. *** Serial 01946 [or "00492"]," (leaflet in ctn.) "Look Younger-Prettier-After 5 Minutes With Your Beauti-Vator." ACCOMPANYING LABELING: Leaflets entitled "A New Beauty Experience" and sales manuals. RESULTS OF INVESTIGATION: The article consisted of a padded headrest attached to a housing containing an electric motor capable of transmitting vibration-like action to a chinstrap fastened to both ends of the motor shaft. LIBELED: 5-27-59, Dist. Minn. CHARGE: 502(a)-when shipped, the labeling contained false and misleading representations that the article was an adequate and effective treatment for causing one to look younger and prettier; improving facial form, texture, and color; stimulating circulation; firming sagging cheek and chin tissues; eliminating lines, furrows, and excess fat, wrinkles and double chin, erasing tiny blemishes; easing nervous tension; slimming and contouring; restoring youthful complexion; replacing and revitalizing dead-looking skin; and for providing a radiant and youthful glow and appearance, and improved beauty. DISPOSITION: 7-8-59. Consent-claimed by Posturamic System, Inc., St. Louis, Mo., and relabeled. 6027. Relax-A-Lounge. (F.D.C. No. 42236. S. No. 12-047 P.) QUANTITY: 34 devices individually cartoned at Chicago, Ill. SHIPPED: 10-7-58, from Los Angeles, Calif., by Relax-A-Cushion, Inc. LABEL IN PART: (Ctn.) "Topper Relax-A-Lounge Health Unit * * * Model L. S. Ser. No. 000490." ACCOMPANYING LABELING: (Leaflet) "Topper Relax-A-Lounge 3-Way Systems Reduce at Home-Relax at Home-Health at Home. RESULTS OF INVESTIGATION: The article was a box-type unit containing an electric motor capable of providing controlled vibrations of 100 to 3,000 actions per minute and fitted with tubular attachments to provide a cot-like device for applying the vibrations to an individual in a reclining position. LIBELED: 10-21-58, N. Dist. Ill. CHARGE: 502(a)—when shipped, the labeling contained false and misleading representations that the article was an adequate and effective treatment for rheumatism, bursitis, and arthritis; stimulating and promoting circulation; breaking down fatty tissues; relief of muscular aches and pains; relieving tension; and reducing weight without diet. DISPOSITION: 7-31-59. Consent-claimed by Topper Relax-A-Lounge 3-Way Systems Reduce At Home-Relax At Home-Health At Home and Relax-A-Cushion, Inc., and relabeled. 6028. Relaxor vibrator massager. (F.D.C. No. 42995. S. Nos. 23-499/500 P.) * Stantex RESULTS OF INVESTIGATION: Examination showed that the article was an upholstered cushion containing an electric motor providing vibration, and (10 devices) a heating element. LIBELED: 54-59, S. Dist. Calif. CHARGE: 502 (a)-when shipped, the labeling of the article contained false and misleading representations that the article was an adequate and effective treatment for promoting circulation, easing nervous tension, relieving aching back, firming fatty tissues, and reducing thighs, flabbiness, and bulges. DISPOSITION: 6-17-59. Default-destruction. 6029. Nemectron device. (F.D.C. No. 41567. S. No. 11-958 P.) QUANTITY: 3 devices at Detroit, Mich. SHIPPED: On an unknown date, from Lindau, Germany, by Deutsche Nemectron Gesellschaft m.b.h. LABEL IN PART: (Metal tag on device) "Deutsche Nemectron Gesellschaft m.b.h. * * * Lindau (B) Germany." ACCOMPANYING LABELING: Leaflets entitled "Nemectron The Apparatus For Bio-Electric Treatments." RESULTS OF INVESTIGATION: The article consisted of an electrical apparatus which converted household current into stimulating voltages which were applied to the human body through four applicator pads. LIBELED: 5-23-58, E. Dist. Mich. CHARGE: 502(a)-when shipped and while held for sale, the labeling which accompanied the article contained false and misleading representations that the article was effective for toning the body; strengthening the body; regenerating the tissues; rejuvenating the body; producing beneficial effects on the cells and tissues of the body, including the nerves, muscles, glands, and brains; overcoming the damages and ravages of age; restoring the lost elasticity of the skin; removing deposits of fat (double chin), and obnoxious toxic substances caused by impaired cellular metabolism; removing wrinkles and furrows; improving cellular metabolism; accelerating venous and lymphatic circulation, thus overcoming cellulitis and acne; "normalizing" a condition of underdevelopment of the breasts and overdevelopment of the breasts; overcoming a condition of atonic abdominal muscles; strengthening the feet; eliminating edema and infiltration of the ankle and calf; and overcoming a condition of fallen arches. DISPOSITION: 10-19-59. Default-delivered to Food and Drug Administration. 6030. Mar V Lounge device. (F.D.C. No. 43179. S. No. 53-220 P.) QUANTITY: 50 assembled devices including the component parts consisting of metal frames and canvas covers and oscillators, at Phoenix, Ariz., in the possession of Pretorius Approved Products. SHIPPED: Between 2-1-59 and 5-23-59, the metal frames and canvas covers of the devices were shipped from Los Angeles, Calif., by Inco Co., and the oscillators for the devices were shipped from Los Angeles, Calif., by Crefan Motors. LABEL IN PART: "Mar V Lounge, Model Marvlmatic." ACCOMPANYING LABELING: Pamphlets entitled "Mar V Lounge Can Make You Look and Feel Younger Than You Are!," direction sheets entitled "The Pretorius Rx Lounge," testimonial letters dated 3-2-59 and signed by "A. L. Schram," and a number of guarantee cards. RESULTS OF INVESTIGATION: The assembled device was an adjustable tubular frame, fitted with canvas to provide a cot-like device. A small electric motor, attached to a cross member of the tubular frame provided vibration to the canvas covered frame. LIBELED: 7-23-59, Dist. Ariz. CHARGE: 502(a)—the labeling accompanying the article, when shipped and while held for sale, contained false and misleading representations that the device was an adequate and effective treatment for slenderizing, toning and firming the muscles, trimming hips and thighs, increasing weight, overcoming back ailments, controlling weight, improving posture, overcoming tension, toning and lifting sagging tissues and relieving pain caused by tension, and congestion in the tissues. DISPOSITION: 9-1-59. Consent-claimed by Martin Pretorius, Phoenix, Ariz., and relabeled. 6031. Nemectrodyn device. (F.D.C. No. 41868. S. No. 11-450 P.) QUANTITY: 1 device at Birmingham, Mich. SHIPPED: On an unknown date from Lindau, Germany, by Deutsche Nemectron Gesellschaft m.b.h. LABEL IN PART: (Metal tag) “Nemectrodyn.” ACCOMPANYING LABELING: Leaflets entitled "Nemectrodyn InterferenceTherapy (Physiotherapy)." RESULTS OF INVESTIGATION: The device consisted of an electrical apparatus which converted household current into stimulating voltages which were applied to the human body through applicator pads. LIBELED: 6-23-58, E. Dist. Mich. CHARGE: 502(a)—when shipped and while held for sale, the labeling which accompanied the article contained false and misleading representations that the article was an adequate and effective treatment for overcoming chronic inflammatory infiltrations, relieving atonic or paralyzed muscles, overcoming ankylosis, producing a beneficial effect on the secretory and excretory glands, overcoming ptosis, hypoperistalsis, subacidity, atony of the intestines, atonic obstipation, statis of the lymph and venous flow, atony and paresis of the striated muscle, intermittent claudication, Raynaud's disease, neuritis, neuralgia, sciatica, arthritis, rheumatism, salpingo-ovaritis, prostatitis, ulcus ventriculi et duodeni, spastic pain, irritation of the autonomic nerve system, and for providing an analgesic sedative and spasmolytic therapy. DISPOSITION: 7-30-59. Default-delivered to the Food and Drug Administration. 6032. Trimform devices. (F.D.C. No. 43014. S. No. 46-320 P.) QUANTITY: 9 individually cartoned devices at New Orleans, La., in possession of Trimform of Louisiana, Inc. SHIPPED: 3-24-59, from North Hollywood, Calif., by Wizard Trimform Sales Co., Inc. LABEL IN PART: (Device) "Trimform by Wizard *** North Hollywood, Calif." ACCOMPANYING LABELING: Leaflets entitled "The Miracle of Trimform" and leaflets and cards entitled “A New Discovery." RESULTS OF INVESTIGATION: The cards entitled "A New Discovery" were printed locally for the dealer. The article consisted of a box-like housing enclosing an electric vibrating motor and fitted on top with an upholstered cushion through which vibrations were transmitted; removable extensions attached to either side of the motor housing comprised the "Trimform" table. LIBELED: 5-19-59, E. Dist. La. CHARGE: 502(a)—when shipped and while held for sale, the labeling of the article contained false and misleading representations that the article was an adequate and effective treatment for spot reducing; providing a healthier life; improving posture; relieving tension and thereby eliminating the cause of many serious ailments; increasing circulation; reducing weight; maintaining body proportions for entire life; firming flabby tissues; and trimming the figure. DISPOSITION: 6-26-59. Consent-claimed by Wizard Trimform Sales Co., Inc., North Hollywood, Calif., and relabeled. 6033. Bobrich vibrator. (F.D.C. No. 41818. S. No. 26-552 P.) QUANTITY: 90 individually cartoned devices at Minneapolis, Minn. SHIPPED: 5-8-58, from New York, N.Y., by Bobrich Products Co. LABEL IN PART: (Ctn.) "Bobrich Salon Type Vibrator Large Professional Size * **Bobrich Products Corporation, New York, N.Y. * * RelaxReduce-Massage-Revitalize." ACCOMPANYING LABELING: Instruction sheet in each carton. RESULTS OF INVESTIGATION: The article was an upholstered, solid-frame cushion, containing an electric motor providing vibration. LIBELED: 6-24-58, Dist. Minn. CHARGE: 502(a)—when shipped, the labeling of the article contained false and misleading representations that the article was an adequate and effective treatment for easing nervous tension, revitalizing, reducing, increasing blood circulation, soothing aches and pains, and disposing of excess fatty tissues. DISPOSITION: 7-22-58. Consent-claimed by S. S. Hollender, Inc., Chicago, Ill., and relabeled. 6034. Relax-4-Life Vibrating Chair. (F.D.C. No. 43032. S. No. 52-552 P.) QUANTITY: 5 chairs at Minneapolis, Minn. SHIPPED: 3-23–59 and 3–30-59, from Santa Rosa, Calif., by Relax-4-Life Co. ACCOMPANYING LABELING: Leaflets entitled "Relax-4-Life," "Healthtone," and "Operating Instructions for Relax-4-Life Chair." RESULTS OF INVESTIGATION: The article was an adjustable, reclining, upholstered chair containing polyfoam cushioning and a motor capable of providing vi brations. LIBELED: 5-27-59, Dist. Minn. CHARGE: 502(a)—when shipped, the labeling, namely, the above-described leaflets, contained false and misleading representations that the article was an adequate and effective treatment for relieving tension, headaches, backaches, poor circulation, arthritis, bursitis, and rheumatism; building health; and toning muscles. DISPOSITION: 8-27-59. Consent-claimed by Joseph E. McCann, t/a Relax4-Life Co., and relabeled. 6035. Temp-rite Mattrest mattress. (F.D.C. No. 42566. S. No. 7-879 P.) QUANTITY: 4 full-size and 5 twin-size mattresses at Manchester, N.H. SHIPPED: 10-21-58 and 11-4-58, and on other unknown dates, from Worcester, Mass., by Worcester Bedding Co. * Manufactured * LABEL IN PART: "Posture Quilt's Temp-rite Mattress * by Posture Quilt of Worcester, Massachusetts." ACCOMPANYING LABELING: Placards entitled "You Will Enjoy Better Health"; leaflets entitled "Now! Dial the sleeping temperature you like best"; and "Relieves Arthritis-Rheumatism While you Sleep! * * Temp-rite Mattrest"; and window streamers entitled "Posture Quilt's Temp-rite Mattrest." RESULTS OF INVESTIGATION: The article was similar to a conventional mattress, but contained a rheostatically controlled heating element. LIBELED: 12-15-58, Dist. N.H. CHARGE: 502(a)—when shipped, the labeling accompanying the article contained false and misleading representations that the article was an adequate and effective treatment for relieving arthritis, bursitis, rheumatism, and insomnia. DISPOSITION: 8-25-59. Consent-the labeling was destroyed and the article was delivered to a local hospital for its use. 6036. Relaxalon vibrating cushion. (F.D.C. No. 42734. S. No. 18-914 P.) QUANTITY: 2 individually cartoned devices at Denver, Colo., in possession of Dave Cook Sporting Goods Co. SHIPPED: 1-19-59, and on an unknown date, from Huntington Park, Calif., by U.S. Chaircraft Mfg. Corp. LABEL IN PART: (Device) "Relaxalon * * (leaflet in ctn.) “Your Guide To A Happier Life." Huntington Park, California"; ACCOMPANYING LABELING: Display placard entitled "Relaxalon." RESULTS OF INVESTIGATION: The device consisted of a box-shaped housing containing an electric motor capable of providing vibrating or oscillating motion to an upholstered cushion attached to the top of the housing. The display placard was prepared by the dealer from a newspaper advertisement. LIBELED: 3-24-59, Dist. Colo. CHARGE: 502 (a)-when shipped and while held for sale, the labeling of the device contained false and misleading representations that the article was an adequate and effective treatment for relieving aches, pains, and miseries; increasing blood circulation; breaking down fatty tissue; improving posture; increasing weight; reducing weight without diets; conditioning feet, head, neck, and shoulders; and slimming the hips. |