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FDA 510(k), K181759, PowerDot PD-01MT
FDA 510(k), K181759, PowerDot PD-01MT
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$149.00 USD
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510(K) Number: K181759
Device Name: PowerDot PD-01MT
Manufacturer: Alexey Pisarev
Device Classification Name: Stimulator, Muscle, Powered
Regulation Number: IPF
Classification Product Code: 07/02/2018
Date Received: 11/09/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
Device Name: PowerDot PD-01MT
Manufacturer: Alexey Pisarev
Device Classification Name: Stimulator, Muscle, Powered
Regulation Number: IPF
Classification Product Code: 07/02/2018
Date Received: 11/09/2018
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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