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FDA 510(k)

EMS/TENS Massager Device

K-Number: K233040 · 2024-02-12

ApplicantShenzhen Imdk Medical Technology Co., Ltd.
Decision Date2024-02-12
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMS/TENS Massager Device is a medical device manufactured by Shenzhen Imdk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-12 under approval number K233040. 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 EMS/TENS Massager Device?

EMS/TENS Massager Device is a medical device that received FDA 510(k) clearance on 2024-02-12. It is manufactured by Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K233040.

When was EMS/TENS Massager Device approved by the FDA?

EMS/TENS Massager Device received FDA 510(k) clearance on 2024-02-12, under approval number K233040.

What company makes EMS/TENS Massager Device?

EMS/TENS Massager Device is manufactured by Shenzhen Imdk Medical Technology Co., Ltd..

What is the FDA product code for EMS/TENS Massager Device?

The FDA product code for EMS/TENS Massager Device is NUH.

Other Devices by Shenzhen Imdk Medical Technology Co., Ltd.

K173123Pulse Oximeter K180419Ultrasonic Doppler (Model YM-2T8) K221979Pulse Oximeter (Model C101A2, C101B1, C101A3) K243118Arm Blood Pressure Monitor (model: BPM-A7VL) K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) K253133Wrist Blood Pressure Monitor (BPM-W1VL)

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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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