FDA 510(k)

Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)

N.º K: K182136 · 2019-10-10

SolicitanteShenzhen Osto Technology Co., Ltd.

Fecha de decisión2019-10-10

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-10-10 under 510(k) number K182136. 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 Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)?

Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K182136.

When did Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) receive FDA 510(k) clearance?

Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) received FDA 510(k) clearance on 2019-10-10, under 510(k) number K182136.

Who is the listed applicant for Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)?

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

What is the FDA product code for Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)?

The FDA product code for Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) is NUH.

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

K212989Low-frequency Stimulator (Model: AST-645, AST-646)K172897Neck Care Therapy, Model: SYK 509B K172837Low-frequency Multi-function physiotherapy instrument K172834Dual output digital therapy massager

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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