FDA 510(k)

LL TENS 160A, LL TENS 160B

N.º K: K152374 · 2016-01-13

Fecha de decisión2016-01-13

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

LL TENS 160A, LL TENS 160B is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Dynamics , Ltd.. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K152374. 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 LL TENS 160A, LL TENS 160B?

LL TENS 160A, LL TENS 160B is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Fuji Dynamics , Ltd.. The 510(k) number is K152374.

When did LL TENS 160A, LL TENS 160B receive FDA 510(k) clearance?

LL TENS 160A, LL TENS 160B received FDA 510(k) clearance on 2016-01-13, under 510(k) number K152374.

Who is the listed applicant for LL TENS 160A, LL TENS 160B?

The FDA 510(k) record lists Fuji Dynamics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LL TENS 160A, LL TENS 160B?

The FDA product code for LL TENS 160A, LL TENS 160B is NUH.

Otros registros que enlistan a Fuji Dynamics , Ltd. como solicitante

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.

K161055Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 K152676FD TENS 2090, FD TENS 2095

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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