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FDA Product Code

FDA Product Code OTX — Clearance Directory

Device Class
Class I
Assigned Panel
Physical Medicine
21 CFR Citation
890.5760

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
DEN110009 RESTLESS LEG DEVICE Mary M. Sorg (An Individual) Dba PJ Sleeper'S 2013-12-18 Post-NSE —

Product code OTX · Class I · Physical Medicine. Data: openFDA.