FDA 510(k)

iStim S2 OTC Pain Relief TENS

N.º K: K181849 · 2018-08-10

SolicitanteEveryway Medical Instruments Co., Ldt.

Fecha de decisión2018-08-10

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

iStim S2 OTC Pain Relief TENS is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co., Ldt.. It received FDA 510(k) clearance on 2018-08-10 under 510(k) number K181849. 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 iStim S2 OTC Pain Relief TENS?

iStim S2 OTC Pain Relief TENS is a medical device that received FDA 510(k) clearance on 2018-08-10. The listed applicant is Everyway Medical Instruments Co., Ldt.. The 510(k) number is K181849.

When did iStim S2 OTC Pain Relief TENS receive FDA 510(k) clearance?

iStim S2 OTC Pain Relief TENS received FDA 510(k) clearance on 2018-08-10, under 510(k) number K181849.

Who is the listed applicant for iStim S2 OTC Pain Relief TENS?

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

What is the FDA product code for iStim S2 OTC Pain Relief TENS?

The FDA product code for iStim S2 OTC Pain Relief TENS is NUH.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

K181207Balego TENS Digital Edition with Accessories for Pain Relief (OTC)

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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