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FDA 510(k)

Transcutaneous Electrical Nerve Stimulator

K-Number: K210223 · 2021-12-15

ApplicantTop-Rank Health Care Co., Ltd.
Decision Date2021-12-15
Product CodeNUH
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 Top-Rank Health Care Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K210223. 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 Transcutaneous Electrical Nerve Stimulator?

Transcutaneous Electrical Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Top-Rank Health Care Co., Ltd.. The 510(k) number is K210223.

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

Transcutaneous Electrical Nerve Stimulator received FDA 510(k) clearance on 2021-12-15, under 510(k) number K210223.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator?

The FDA 510(k) record lists Top-Rank Health Care 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 NUH.

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 Top-Rank Health Care 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.

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Related Devices (Code: NUH)

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.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics LimitedK251958VEINOPLUS BackDynapulse Medical

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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