FDA 510(k)

EMS/TENS Massager Device

N.º K: K233040 · 2024-02-12

SolicitanteShenzhen Imdk Medical Technology Co., Ltd.

Fecha de decisión2024-02-12

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

EMS/TENS Massager Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-12 under 510(k) number K233040. 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 EMS/TENS Massager Device?

EMS/TENS Massager Device is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K233040.

When did EMS/TENS Massager Device receive FDA 510(k) clearance?

EMS/TENS Massager Device received FDA 510(k) clearance on 2024-02-12, under 510(k) number K233040.

Who is the listed applicant for EMS/TENS Massager Device?

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

What is the FDA product code for EMS/TENS Massager Device?

The FDA product code for EMS/TENS Massager Device is NUH.

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Otros registros que enlistan a Shenzhen Imdk Medical Technology Co., Ltd. como solicitante

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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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