FDA 510(k)

Dual output digital therapy massager

N.º K: K172834 · 2018-09-06

SolicitanteShenzhen Osto Technology Co., Ltd.

Fecha de decisión2018-09-06

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Dual output digital therapy massager 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 2018-09-06 under 510(k) number K172834. 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 Dual output digital therapy massager?

Dual output digital therapy massager is a medical device that received FDA 510(k) clearance on 2018-09-06. The listed applicant is Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K172834.

When did Dual output digital therapy massager receive FDA 510(k) clearance?

Dual output digital therapy massager received FDA 510(k) clearance on 2018-09-06, under 510(k) number K172834.

Who is the listed applicant for Dual output digital therapy massager?

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 Dual output digital therapy massager?

The FDA product code for Dual output digital therapy massager 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)K182136Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)K172897Neck Care Therapy, Model: SYK 509B K172837Low-frequency Multi-function physiotherapy instrument

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

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