FDA 510(k)

OTC 4-Channel Rechargeable TENS Unit

N.º K: K251429 · 2025-08-28

SolicitanteChangsha Anxiang Medical Technology Co., Ltd.

Fecha de decisión2025-08-28

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

OTC 4-Channel Rechargeable TENS Unit is the device name listed in this FDA 510(k) record. The listed applicant is Changsha Anxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K251429. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the OTC 4-Channel Rechargeable TENS Unit?

OTC 4-Channel Rechargeable TENS Unit is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is Changsha Anxiang Medical Technology Co., Ltd.. The 510(k) number is K251429.

When did OTC 4-Channel Rechargeable TENS Unit receive FDA 510(k) clearance?

OTC 4-Channel Rechargeable TENS Unit received FDA 510(k) clearance on 2025-08-28, under 510(k) number K251429.

Who is the listed applicant for OTC 4-Channel Rechargeable TENS Unit?

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

What is the FDA product code for OTC 4-Channel Rechargeable TENS Unit?

The FDA product code for OTC 4-Channel Rechargeable TENS Unit is NUH.

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Otros registros que enlistan a Changsha Anxiang Medical Technology Co., Ltd. como solicitante

K251706TENS and EMS Unit K251187UNIDAD TENS DE 3 EN 1 (TC1241, TC2241, TS1241)K250759UNIDAD TENS DE 3 EN 1 K243763Wireless TENS & EMS Unit K243511OTC TENS & EMS Unit K242787Tens & Ems Device (TU1080)

Ver todos los 8 dispositivos →

Dispositivos relacionados (Código: 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

Fuente oficial

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