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FDA 510(k)

JIAJIAN TENS

K-Number: K112288 · 2012-05-02

ApplicantWuxi Jiajian Medical Instrument Co., Ltd.
Decision Date2012-05-02
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

JIAJIAN TENS is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Jiajian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2012-05-02 under 510(k) number K112288. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JIAJIAN TENS?

JIAJIAN TENS is a medical device that received FDA 510(k) clearance on 2012-05-02. The listed applicant is Wuxi Jiajian Medical Instrument Co., Ltd.. The 510(k) number is K112288.

When did JIAJIAN TENS receive FDA 510(k) clearance?

JIAJIAN TENS received FDA 510(k) clearance on 2012-05-02, under 510(k) number K112288.

Who is the listed applicant for JIAJIAN TENS?

The FDA 510(k) record lists Wuxi Jiajian Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JIAJIAN TENS?

The FDA product code for JIAJIAN TENS is GZJ.

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Other records listing Wuxi Jiajian Medical Instrument Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K244030Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)K231425Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)K222879Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)K202861Needle StimulatorK202893Transcutaneous Electrical Nerve StimulatorK192568Jiajian Self-Adhesive Electrode

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Related Devices (Code: GZJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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