FDA 510(k)

Wireless TENS/EMS, Bruno, Aela

K-Number: K220997 · 2022-09-01

Decision Date2022-09-01

Product CodeNUH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Wireless TENS/EMS, Bruno, Aela is a medical device manufactured by Zmi Elecronics , Ltd.. It received FDA 510(k) clearance on 2022-09-01 under approval number K220997. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wireless TENS/EMS, Bruno, Aela?

Wireless TENS/EMS, Bruno, Aela is a medical device that received FDA 510(k) clearance on 2022-09-01. It is manufactured by Zmi Elecronics , Ltd.. The 510(k) number is K220997.

When was Wireless TENS/EMS, Bruno, Aela approved by the FDA?

Wireless TENS/EMS, Bruno, Aela received FDA 510(k) clearance on 2022-09-01, under approval number K220997.

What company makes Wireless TENS/EMS, Bruno, Aela?

Wireless TENS/EMS, Bruno, Aela is manufactured by Zmi Elecronics , Ltd..

What is the FDA product code for Wireless TENS/EMS, Bruno, Aela?

The FDA product code for Wireless TENS/EMS, Bruno, Aela is NUH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.