6561. Ultra-Sonic device.   (F.D.C. No. 44591.   S. No. 43-699 R.)
QUANTITY :   1 device at Great Falls, Mont., in possession of Elizabeth Webb Hill.
SHIPPED :   8-14-59, from Los Angeles, Calif., by Ace Medical Instrument Co.
LABEL IN PAET: (Metal plate on device) "Ace Ultra-Sonic * * * Manufac- 
tured by Electronics Instrument Co., Los Angeles, Calif."
ACCOMPANYING LABELING: Leaflets entitled "Operating Instructions" and "Ace 
Ultra-Sonic Deluxe Model."
RESULTS OF INVESTIGATION : Examination indicated the device to be an elec- 
tronic device producing ultrasound energy at 960,000 eycles per second 
through a 10 square centimeter sound head.   The instrument cabinets con-
tained an oscillator and power supply. The fruit panel contained a timer, 
intensity control, and power output meter.
CHARGE: 502(f) (1)-when shipped, the labeling of the article failed to bear 
adequate directions for use for the purposes for which it was intended, 
namely, the treatment of disease or abnormal conditions of the nerves, head, 
neck, shoulders, thoracic region, lumbosacral region, arteries, joints, upper 
extremity, and lower extremity; 502(f) (1)-while held for sale, the labeling 
of the article failed to bear adequate directions for use for any condition 
and it was not exempt under the provisions of Regulation 21 CFR 1.106(d) 
from bearing adequate directions for use since it was a prescription device 
sold to and in possession of a person not entitled to use such a device.
DISPOSITION : 10-20-60. Consent-claimed by W. M. Jacobson, t/a Ace Medical 
Instrument Co. and relabeled.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FROM
OFFICIAL OR OWN STANDARDS*