FDA 510(k)

UNIDAD TENS DE 3 EN 1 (TC1241, TC2241, TS1241)

N.º K: K251187 · 2025-07-28

SolicitanteChangsha Anxiang Medical Technology Co., Ltd.

Fecha de decisión2025-07-28

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

3 in 1 TENS UNIT (TC1241, TC2241, TS1241) 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 2025-07-28 under 510(k) number K251187. 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 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)?

3 in 1 TENS UNIT (TC1241, TC2241, TS1241) is a medical device that received FDA 510(k) clearance on 2025-07-28. The listed applicant is Changsha Anxiang Medical Technology Co., Ltd.. The 510(k) number is K251187.

When did 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) receive FDA 510(k) clearance?

3 in 1 TENS UNIT (TC1241, TC2241, TS1241) received FDA 510(k) clearance on 2025-07-28, under 510(k) number K251187.

Who is the listed applicant for 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)?

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 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)?

The FDA product code for 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) is NUH.

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

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K251429OTC 4-Channel Rechargeable TENS Unit K251706TENS and EMS Unit 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

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.