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FDA 510(k)

Wireless TENS & EMS (Model SM9110,SM9113,SM9116)

K-Number: K233067 · 2024-07-19

ApplicantChongqing Rob Linka Science and Technology Co., Ltd.
Decision Date2024-07-19
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Wireless TENS & EMS (Model SM9110,SM9113,SM9116) is a medical device manufactured by Chongqing Rob Linka Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-07-19 under approval number K233067. 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 (Model SM9110,SM9113,SM9116)?

Wireless TENS & EMS (Model SM9110,SM9113,SM9116) is a medical device that received FDA 510(k) clearance on 2024-07-19. It is manufactured by Chongqing Rob Linka Science and Technology Co., Ltd.. The 510(k) number is K233067.

When was Wireless TENS & EMS (Model SM9110,SM9113,SM9116) approved by the FDA?

Wireless TENS & EMS (Model SM9110,SM9113,SM9116) received FDA 510(k) clearance on 2024-07-19, under approval number K233067.

What company makes Wireless TENS & EMS (Model SM9110,SM9113,SM9116)?

Wireless TENS & EMS (Model SM9110,SM9113,SM9116) is manufactured by Chongqing Rob Linka Science and Technology Co., Ltd..

What is the FDA product code for Wireless TENS & EMS (Model SM9110,SM9113,SM9116)?

The FDA product code for Wireless TENS & EMS (Model SM9110,SM9113,SM9116) is NUH.

Other Devices by Chongqing Rob Linka Science and Technology Co., Ltd.

K230829TENS7000 Rechargeable (Model:TENS7000 Rechargeable) K233070Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) K233092Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)

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.

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