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FDA 510(k)

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)

K-Number: K233092 · 2024-02-12

ApplicantChongqing Rob Linka Science and Technology Co., Ltd.
Decision Date2024-02-12
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) is a medical device manufactured by Chongqing Rob Linka Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-12 under approval number K233092. 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 Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)?

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) is a medical device that received FDA 510(k) clearance on 2024-02-12. It is manufactured by Chongqing Rob Linka Science and Technology Co., Ltd.. The 510(k) number is K233092.

When was Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) approved by the FDA?

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) received FDA 510(k) clearance on 2024-02-12, under approval number K233092.

What company makes Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)?

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) is manufactured by Chongqing Rob Linka Science and Technology Co., Ltd..

What is the FDA product code for Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)?

The FDA product code for Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) is NUH.

Related Clinical Trials

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Related PubMed Literature

PMID: 41072144 Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices. Computers in biology and medicine (2025) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025) PMID: 40290478 Mental health apps in India: regulatory landscape and future directions. BJPsych international (2025)

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

K230829TENS7000 Rechargeable (Model:TENS7000 Rechargeable) K233067Wireless TENS & EMS (Model SM9110,SM9113,SM9116) K233070Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)

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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