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FDA 510(k), K220997, Wireless TENS/EMS, Bruno, Aela
FDA 510(k), K220997, Wireless TENS/EMS, Bruno, Aela
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510(K) Number: K220997
Device Name: Wireless TENS/EMS, Bruno, Aela
Manufacturer: ZMI Elecronics Ltd.
Device Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 04/04/2022
Decision Date: 09/01/2022
Regulation Medical Specialty: Neurology
Device Name: Wireless TENS/EMS, Bruno, Aela
Manufacturer: ZMI Elecronics Ltd.
Device Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 04/04/2022
Decision Date: 09/01/2022
Regulation Medical Specialty: Neurology
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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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