FDA 510(k)

Health Expert Electronic Stimulator (model: AST-300L)

N.º K: K190783 · 2020-03-14

SolicitanteShenzhen Osto Technology Company Limited

Fecha de decisión2020-03-14

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Health Expert Electronic Stimulator (model: AST-300L) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Company Limited. It received FDA 510(k) clearance on 2020-03-14 under 510(k) number K190783. 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 Health Expert Electronic Stimulator (model: AST-300L)?

Health Expert Electronic Stimulator (model: AST-300L) is a medical device that received FDA 510(k) clearance on 2020-03-14. The listed applicant is Shenzhen Osto Technology Company Limited. The 510(k) number is K190783.

When did Health Expert Electronic Stimulator (model: AST-300L) receive FDA 510(k) clearance?

Health Expert Electronic Stimulator (model: AST-300L) received FDA 510(k) clearance on 2020-03-14, under 510(k) number K190783.

Who is the listed applicant for Health Expert Electronic Stimulator (model: AST-300L)?

The FDA 510(k) record lists Shenzhen Osto Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Health Expert Electronic Stimulator (model: AST-300L)?

The FDA product code for Health Expert Electronic Stimulator (model: AST-300L) is NUH.

Ensayos clínicos relacionados

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Otros registros que enlistan a Shenzhen Osto Technology Company Limited como solicitante

K213056LED Facial Mask K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)K211736Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)K210756Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H K190673Health Expert Electronic Stimulator

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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