FDA 510(k)

Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)

K-Nummer: K250784 · 2025-08-21

AntragstellerShenzhen Yicai Health Technology Co., Ltd.

Entscheidungsdatum2025-08-21

ProduktcodeNUH

BeratungsausschussDie Beschreibung des medizinischen Geräts für die regulatorische Zulassung lautet wie folgt: NE (Keine spezifische Beschreibung vorhanden)

EntscheidungSubstantiell Äquivalent

Produktübersicht

Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Yicai Health Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-08-21 under 510(k) number K250784. 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 ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)?

Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) is a medical device that received FDA 510(k) clearance on 2025-08-21. The listed applicant is Shenzhen Yicai Health Technology Co., Ltd.. The 510(k) number is K250784.

When did Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) received FDA 510(k) clearance on 2025-08-21, under 510(k) number K250784.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)?

The FDA 510(k) record lists Shenzhen Yicai Health Technology 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 ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)?

The FDA product code for Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) is NUH.

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Weitere Einträge mit Shenzhen Yicai Health Technology Co., Ltd. als Antragsteller

K251623Luftkompressions-Therapiegerät (K1002/K1006/K1007/K1008/K1061)K241119Transcutaneous Electrical Nerve Stimulator (K6106)

Verwandte Geräte (Code: NUH)

K261131Elektrischer Muskelstimulator (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 wiederaufladbar 4 Kanal (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS-GERÄT (FT-247-Serie) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS-Gerät (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS UND EMS (TENS und Muskelstimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited

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