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FDA 510(k)

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

K-Number: K253305 · 2025-12-31

ApplicantShenzhen Jiantuo Electronics Co., Ltd.
Decision Date2025-12-31
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) is a medical device manufactured by Shenzhen Jiantuo Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-12-31 under approval number K253305. 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 AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)?

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) is a medical device that received FDA 510(k) clearance on 2025-12-31. It is manufactured by Shenzhen Jiantuo Electronics Co., Ltd.. The 510(k) number is K253305.

When was TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) approved by the FDA?

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) received FDA 510(k) clearance on 2025-12-31, under approval number K253305.

What company makes TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)?

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) is manufactured by Shenzhen Jiantuo Electronics Co., Ltd..

What is the FDA product code for TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)?

The FDA product code for TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) is NUH.

Related Clinical Trials

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Other Devices by Shenzhen Jiantuo Electronics Co., Ltd.

K250360TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) K250053TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)

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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