Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TENS and EMS Stimulation (OTC)

K-Number: K230163 · 2023-03-20

ApplicantChangsha Yuwen Medical Equipment Co., Ltd.
Decision Date2023-03-20
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS and EMS Stimulation (OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Changsha Yuwen Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-03-20 under 510(k) number K230163. 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 Stimulation (OTC)?

TENS and EMS Stimulation (OTC) is a medical device that received FDA 510(k) clearance on 2023-03-20. The listed applicant is Changsha Yuwen Medical Equipment Co., Ltd.. The 510(k) number is K230163.

When did TENS and EMS Stimulation (OTC) receive FDA 510(k) clearance?

TENS and EMS Stimulation (OTC) received FDA 510(k) clearance on 2023-03-20, under 510(k) number K230163.

Who is the listed applicant for TENS and EMS Stimulation (OTC)?

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

What is the FDA product code for TENS and EMS Stimulation (OTC)?

The FDA product code for TENS and EMS Stimulation (OTC) is NUH.

Other records listing Changsha Yuwen Medical Equipment 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.

K230164TENS and EMS Stimulation (OTC)K230174TENS and EMS Stimulation (OTC)K212184TENS and EMS Stimulation (OTC)

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.

↑