FDA 510(k), K143551, Compex Wireless USA

FDA 510(k), K143551, Compex Wireless USA

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510(K) Number: K143551
Device Name: Compex Wireless USA
Manufacturer: GINA FLORES
Device Classification Name: Stimulator, Muscle, Powered, For Muscle Conditioning
Regulation Number: NGX
Classification Product Code: KXA
Date Received: 12/15/2014
Decision Date: 04/28/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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