Tyece OTC TENS Model
K-Number: K200838 · 2020-08-12
ApplicantTyece Limited
Decision Date2020-08-12
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Tyece OTC TENS Model is a medical device manufactured by Tyece Limited. It received FDA 510(k) clearance on 2020-08-12 under approval number K200838. 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 Tyece OTC TENS Model?
Tyece OTC TENS Model is a medical device that received FDA 510(k) clearance on 2020-08-12. It is manufactured by Tyece Limited. The 510(k) number is K200838.
When was Tyece OTC TENS Model approved by the FDA?
Tyece OTC TENS Model received FDA 510(k) clearance on 2020-08-12, under approval number K200838.
What company makes Tyece OTC TENS Model?
Tyece OTC TENS Model is manufactured by Tyece Limited.
What is the FDA product code for Tyece OTC TENS Model?
The FDA product code for Tyece OTC TENS Model is NUH.
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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.