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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: 09/06/2016
Date Received: 02/16/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: RF1400 Active Compression Wrap
Manufacturer: Jeff Schwegman
Device Classification Name: Sleeve, Limb, Compressible
Regulation Number: JOW
Classification Product Code: 09/06/2016
Date Received: 02/16/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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