FDA 510(k), K220997, Wireless TENS/EMS, Bruno, Aela

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

1,386 pages (2,357 of 3,743 original pages are fully redacted)