FDA 510(k)

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)

N.º K: K233092 · 2024-02-12

SolicitanteChongqing Rob Linka Science and Technology Co., Ltd.

Fecha de decisión2024-02-12

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) 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 2024-02-12 under 510(k) number K233092. 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 Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)?

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is Chongqing Rob Linka Science and Technology Co., Ltd.. The 510(k) number is K233092.

When did Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) receive FDA 510(k) clearance?

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) received FDA 510(k) clearance on 2024-02-12, under 510(k) number K233092.

Who is the listed applicant for Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)?

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 Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)?

The FDA product code for Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) is NUH.

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

K233067Wireless TENS & EMS (Model SM9110,SM9113,SM9116)K233070Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)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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