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FDA 510(k)

TENS7000 Rechargeable (Model:TENS7000 Rechargeable)

K-Number: K230829 · 2023-04-26

ApplicantChongqing Rob Linka Science and Technology Co., Ltd.
Decision Date2023-04-26
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS7000 Rechargeable (Model:TENS7000 Rechargeable) is a medical device manufactured by Chongqing Rob Linka Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-04-26 under approval number K230829. 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 TENS7000 Rechargeable (Model:TENS7000 Rechargeable)?

TENS7000 Rechargeable (Model:TENS7000 Rechargeable) is a medical device that received FDA 510(k) clearance on 2023-04-26. It is manufactured by Chongqing Rob Linka Science and Technology Co., Ltd.. The 510(k) number is K230829.

When was TENS7000 Rechargeable (Model:TENS7000 Rechargeable) approved by the FDA?

TENS7000 Rechargeable (Model:TENS7000 Rechargeable) received FDA 510(k) clearance on 2023-04-26, under approval number K230829.

What company makes TENS7000 Rechargeable (Model:TENS7000 Rechargeable)?

TENS7000 Rechargeable (Model:TENS7000 Rechargeable) is manufactured by Chongqing Rob Linka Science and Technology Co., Ltd..

What is the FDA product code for TENS7000 Rechargeable (Model:TENS7000 Rechargeable)?

The FDA product code for TENS7000 Rechargeable (Model:TENS7000 Rechargeable) is NUH.

Related Clinical Trials

NCT07499258 Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence NOT_YET_RECRUITING

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

K233067Wireless TENS & EMS (Model SM9110,SM9113,SM9116) 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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