FDA 510(k)

Wireless TENS & EMS (Model SM9110,SM9113,SM9116)

N.º K: K233067 · 2024-07-19

SolicitanteChongqing Rob Linka Science and Technology Co., Ltd.

Fecha de decisión2024-07-19

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Wireless TENS & EMS (Model SM9110,SM9113,SM9116) is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Rob Linka Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-07-19 under 510(k) number K233067. 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 Wireless TENS & EMS (Model SM9110,SM9113,SM9116)?

Wireless TENS & EMS (Model SM9110,SM9113,SM9116) is a medical device that received FDA 510(k) clearance on 2024-07-19. The listed applicant is Chongqing Rob Linka Science and Technology Co., Ltd.. The 510(k) number is K233067.

When did Wireless TENS & EMS (Model SM9110,SM9113,SM9116) receive FDA 510(k) clearance?

Wireless TENS & EMS (Model SM9110,SM9113,SM9116) received FDA 510(k) clearance on 2024-07-19, under 510(k) number K233067.

Who is the listed applicant for Wireless TENS & EMS (Model SM9110,SM9113,SM9116)?

The FDA 510(k) record lists Chongqing Rob Linka Science and Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wireless TENS & EMS (Model SM9110,SM9113,SM9116)?

The FDA product code for Wireless TENS & EMS (Model SM9110,SM9113,SM9116) is NUH.

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Otros registros que enlistan a Chongqing Rob Linka Science and Technology Co., Ltd. como solicitante

K233070Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)K233092Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)K230829TENS7000 Rechargeable (Model:TENS7000 Rechargeable)

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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