FDA 510(k)

Li-Battery powered OTC TENS/EMS Combination Stimulator

N.º K: K201335 · 2020-10-24

SolicitanteEveryway Medical Instruments Co.,Ltd

Fecha de decisión2020-10-24

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Li-Battery powered OTC TENS/EMS Combination Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2020-10-24 under 510(k) number K201335. 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 Li-Battery powered OTC TENS/EMS Combination Stimulator?

Li-Battery powered OTC TENS/EMS Combination Stimulator is a medical device that received FDA 510(k) clearance on 2020-10-24. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K201335.

When did Li-Battery powered OTC TENS/EMS Combination Stimulator receive FDA 510(k) clearance?

Li-Battery powered OTC TENS/EMS Combination Stimulator received FDA 510(k) clearance on 2020-10-24, under 510(k) number K201335.

Who is the listed applicant for Li-Battery powered OTC TENS/EMS Combination Stimulator?

The FDA 510(k) record lists Everyway Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Li-Battery powered OTC TENS/EMS Combination Stimulator?

The FDA product code for Li-Battery powered OTC TENS/EMS Combination Stimulator is NUH.

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Otros registros que enlistan a Everyway Medical Instruments Co.,Ltd como solicitante

K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 K222488Everyway Analog OTC TENS K213116Everyway Incontinence Stimulation System K202849Everyway Analog OTC TENS, model N103A/N302 K202470Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 K202317Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806

Ver todos los 13 dispositivos →

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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