FDA 510(k)

TENS and Muscle Stimulator

N.º K: K200727 · 2020-06-18

SolicitanteShenzhen Astec Technology Co., Ltd.

Fecha de decisión2020-06-18

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

TENS and Muscle Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Astec Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-06-18 under 510(k) number K200727. 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 TENS and Muscle Stimulator?

TENS and Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2020-06-18. The listed applicant is Shenzhen Astec Technology Co., Ltd.. The 510(k) number is K200727.

When did TENS and Muscle Stimulator receive FDA 510(k) clearance?

TENS and Muscle Stimulator received FDA 510(k) clearance on 2020-06-18, under 510(k) number K200727.

Who is the listed applicant for TENS and Muscle Stimulator?

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

What is the FDA product code for TENS and Muscle Stimulator?

The FDA product code for TENS and Muscle Stimulator is NUH.

Ensayos clínicos relacionados

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

K243856TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)

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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