OTC 4-Channel Rechargeable TENS Unit
K-Number: K251429 · 2025-08-28
Decision Date2025-08-28
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
OTC 4-Channel Rechargeable TENS Unit is a medical device manufactured by Changsha Anxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-08-28 under approval number K251429. 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 OTC 4-Channel Rechargeable TENS Unit?
OTC 4-Channel Rechargeable TENS Unit is a medical device that received FDA 510(k) clearance on 2025-08-28. It is manufactured by Changsha Anxiang Medical Technology Co., Ltd.. The 510(k) number is K251429.
When was OTC 4-Channel Rechargeable TENS Unit approved by the FDA?
OTC 4-Channel Rechargeable TENS Unit received FDA 510(k) clearance on 2025-08-28, under approval number K251429.
What company makes OTC 4-Channel Rechargeable TENS Unit?
OTC 4-Channel Rechargeable TENS Unit is manufactured by Changsha Anxiang Medical Technology Co., Ltd..
What is the FDA product code for OTC 4-Channel Rechargeable TENS Unit?
The FDA product code for OTC 4-Channel Rechargeable TENS Unit is NUH.
Other Devices by Changsha Anxiang Medical Technology Co., Ltd.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.