FDA 510(k)

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300

N.º K: K202470 · 2020-11-25

SolicitanteEveryway Medical Instruments Co.,Ltd

Fecha de decisión2020-11-25

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 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 2020-11-25 under 510(k) number K202470. 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, model EM-6000, EM-6100, EM-6200 & EM-6300?

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K202470.

When did Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 receive FDA 510(k) clearance?

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 received FDA 510(k) clearance on 2020-11-25, under 510(k) number K202470.

Who is the listed applicant for Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300?

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, model EM-6000, EM-6100, EM-6200 & EM-6300?

The FDA product code for Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 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 K202317Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 K201335Li-Battery powered OTC TENS/EMS Combination Stimulator

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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