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FDA 510(k)

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)

K-Number: K220578 · 2022-05-25

ApplicantBozhou Rongjian Medical Appliance Co., Ltd.
Decision Date2022-05-25
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) is the device name listed in this FDA 510(k) record. The listed applicant is Bozhou Rongjian Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K220578. 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 (Model RJTENS-1)?

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Bozhou Rongjian Medical Appliance Co., Ltd.. The 510(k) number is K220578.

When did Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) received FDA 510(k) clearance on 2022-05-25, under 510(k) number K220578.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)?

The FDA 510(k) record lists Bozhou Rongjian Medical Appliance 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 (Model RJTENS-1)?

The FDA product code for Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) 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.

NCT05348005Use of TENS Unit in the Management of Endometriosis PainCOMPLETEDNCT06411054The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVARECRUITINGNCT06619418Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back PainRECRUITINGNCT07543302Can 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 PatientsRECRUITING

Other records listing Bozhou Rongjian Medical Appliance 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.

K252688Transcutaneous Electrical Nerve Stimulator (RJTENS-2)K220153Needle Stimulator (Model: RJNS6-1)K213879Self-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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