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FDA 510(k)

Transcutaneous Electrical Nerve Stimulator

K-Number: K202893 · 2021-06-18

ApplicantWuxi Jiajian Medical Instrument Co., Ltd.
Decision Date2021-06-18
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Transcutaneous Electrical Nerve Stimulator 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 2021-06-18 under 510(k) number K202893. 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 Transcutaneous Electrical Nerve Stimulator?

Transcutaneous Electrical Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2021-06-18. The listed applicant is Wuxi Jiajian Medical Instrument Co., Ltd.. The 510(k) number is K202893.

When did Transcutaneous Electrical Nerve Stimulator receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator received FDA 510(k) clearance on 2021-06-18, under 510(k) number K202893.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator?

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 Transcutaneous Electrical Nerve Stimulator?

The FDA product code for Transcutaneous Electrical Nerve Stimulator is GZJ.

Related Clinical Trials

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.

NCT06411054The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVARECRUITINGNCT07543302Can External Vagus Nerve Stimulation Reduce Systemic Levels of Inflammatory Mediators in Duchenne Muscular Dystrophy Patients?ENROLLING_BY_INVITATIONNCT07548723taVNS During Multi-site HRV Measurement: Reliability & Agreement StudyENROLLING_BY_INVITATIONNCT07569705Effect of Transcutaneous Electrical Nerve Stimulation on PODD in Bariatric Surgery PatientsRECRUITINGNCT05348005Use of TENS Unit in the Management of Endometriosis PainCOMPLETEDNCT06619418Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back PainRECRUITING

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 StimulatorK192568Jiajian Self-Adhesive Electrode

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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