FDA 510(k)

Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)

K-Nummer: K231425 · 2024-03-27

AntragstellerWuxi Jiajian Medical Instrument Co., Ltd.

Entscheidungsdatum2024-03-27

ProduktcodeNUH

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) 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 2024-03-27 under 510(k) number K231425. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)?

Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) is a medical device that received FDA 510(k) clearance on 2024-03-27. The listed applicant is Wuxi Jiajian Medical Instrument Co., Ltd.. The 510(k) number is K231425.

When did Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) received FDA 510(k) clearance on 2024-03-27, under 510(k) number K231425.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)?

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 (TENS WMPS2-1)?

The FDA product code for Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) is NUH.

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Weitere Einträge mit Wuxi Jiajian Medical Instrument Co., Ltd. als Antragsteller

K244030Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)K222879Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)K202861Needle Stimulator K202893Transcutaneous Electrical Nerve Stimulator K192568Jiajian Self-Adhesive Electrode

Verwandte Geräte (Code: NUH)

K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Shenzhen Osto Medical Technology Co.,Ltd 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 Limited

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