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FDA 510(k), K152432, ActiPatch(R)
FDA 510(k), K152432, ActiPatch(R)
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510(K) Number: K152432
Device Name: ActiPatch(R)
Manufacturer: ANDREW WHELAN
Device Classification Name: Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Regulation Number: PQY
Classification Product Code: 08/27/2015
Date Received: 02/03/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
Device Name: ActiPatch(R)
Manufacturer: ANDREW WHELAN
Device Classification Name: Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Regulation Number: PQY
Classification Product Code: 08/27/2015
Date Received: 02/03/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
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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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