FDA 510(k), K162481, RF1400 Active Compression Wrap

FDA 510(k), K162481, RF1400 Active Compression Wrap

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510(K) Number: K162481
Device Name: RF1400 Active Compression Wrap
Manufacturer: Jeff Schwegman
Device Classification Name: Sleeve, Limb, Compressible
Regulation Number: JOW
Classification Product Code: KXA
Date Received: 09/06/2016
Decision Date: 02/16/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
  • 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. Learn more about Fast-Track Requests here.

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