TENS and EMS Stimulation (OTC)
K-Number: K212184 · 2022-04-01
Decision Date2022-04-01
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
TENS and EMS Stimulation (OTC) is a medical device manufactured by Changsha Yuwen Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-04-01 under approval number K212184. 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 TENS and EMS Stimulation (OTC)?
TENS and EMS Stimulation (OTC) is a medical device that received FDA 510(k) clearance on 2022-04-01. It is manufactured by Changsha Yuwen Medical Equipment Co., Ltd.. The 510(k) number is K212184.
When was TENS and EMS Stimulation (OTC) approved by the FDA?
TENS and EMS Stimulation (OTC) received FDA 510(k) clearance on 2022-04-01, under approval number K212184.
What company makes TENS and EMS Stimulation (OTC)?
TENS and EMS Stimulation (OTC) is manufactured by Changsha Yuwen Medical Equipment Co., Ltd..
What is the FDA product code for TENS and EMS Stimulation (OTC)?
The FDA product code for TENS and EMS Stimulation (OTC) is NUH.
Other Devices by Changsha Yuwen Medical Equipment 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.