FDA 510(k)

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

N.º K: K181207 · 2018-06-06

SolicitanteEveryway Medical Instruments Co., Ldt.

Fecha de decisión2018-06-06

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Balego TENS Digital Edition with Accessories for Pain Relief (OTC) 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 2018-06-06 under 510(k) number K181207. 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 Balego TENS Digital Edition with Accessories for Pain Relief (OTC)?

Balego TENS Digital Edition with Accessories for Pain Relief (OTC) is a medical device that received FDA 510(k) clearance on 2018-06-06. The listed applicant is Everyway Medical Instruments Co., Ldt.. The 510(k) number is K181207.

When did Balego TENS Digital Edition with Accessories for Pain Relief (OTC) receive FDA 510(k) clearance?

Balego TENS Digital Edition with Accessories for Pain Relief (OTC) received FDA 510(k) clearance on 2018-06-06, under 510(k) number K181207.

Who is the listed applicant for Balego TENS Digital Edition with Accessories for Pain Relief (OTC)?

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 Balego TENS Digital Edition with Accessories for Pain Relief (OTC)?

The FDA product code for Balego TENS Digital Edition with Accessories for Pain Relief (OTC) is NUH.

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

K181849iStim S2 OTC Pain Relief TENS

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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