TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
K-Number: K230443 · 2023-05-22
Decision Date2023-05-22
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) is a medical device manufactured by Jiangxi Royall Smart Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-22 under approval number K230443. 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 & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)?
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) is a medical device that received FDA 510(k) clearance on 2023-05-22. It is manufactured by Jiangxi Royall Smart Technology Co., Ltd.. The 510(k) number is K230443.
When was TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) approved by the FDA?
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) received FDA 510(k) clearance on 2023-05-22, under approval number K230443.
What company makes TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)?
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) is manufactured by Jiangxi Royall Smart Technology Co., Ltd..
What is the FDA product code for TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)?
The FDA product code for TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) is NUH.
Related Devices (Code: NUH)
K162630CP Relief Wand-OTCMid-America Medical Innovations, LLC
K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605AWell-Life Healthcare Limited
K160508Electronic Pulse StimulatorBeijing Choice Electronic Technololgy Co., Ltd.
K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd.
K151995Painmaster MCT PatchNewmark, Inc.
K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc.
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.