FDA 510(k), K152432, ActiPatch(R)

FDA 510(k), K152432, ActiPatch(R)

Regular price $89.00 USD
Regular price Sale price $89.00 USD
Sale Sold out
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: KXA
Date Received: 08/27/2015
Decision Date: 02/03/2017
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. Learn more about Fast-Track Requests here.

View full details