FDA 510(k)

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)

N.º K: K233461 · 2024-01-19

Fecha de decisión2024-01-19

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Dow International, Inc.. It received FDA 510(k) clearance on 2024-01-19 under 510(k) number K233461. 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 Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)?

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Hi-Dow International, Inc.. The 510(k) number is K233461.

When did Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) receive FDA 510(k) clearance?

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) received FDA 510(k) clearance on 2024-01-19, under 510(k) number K233461.

Who is the listed applicant for Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)?

The FDA 510(k) record lists Hi-Dow International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)?

The FDA product code for Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) is NUH.

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Otros registros que enlistan a Hi-Dow International, Inc. como solicitante

K210383Wrap Accessory Electrodes K202337Pulsed electromagnetic field wrap K190617Wrap accessory electrodes K163393Hi-Dow Wireless TENS/EMS System (Model HD-5N)

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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