FDA 510(k)

Transcutaneous Electrical Nerve Stimulator (RJTENS-2)

N.º K: K252688 · 2025-11-24

SolicitanteBozhou Rongjian Medical Appliance Co., Ltd.

Fecha de decisión2025-11-24

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Transcutaneous Electrical Nerve Stimulator (RJTENS-2) is the device name listed in this FDA 510(k) record. The listed applicant is Bozhou Rongjian Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2025-11-24 under 510(k) number K252688. 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 Transcutaneous Electrical Nerve Stimulator (RJTENS-2)?

Transcutaneous Electrical Nerve Stimulator (RJTENS-2) is a medical device that received FDA 510(k) clearance on 2025-11-24. The listed applicant is Bozhou Rongjian Medical Appliance Co., Ltd.. The 510(k) number is K252688.

When did Transcutaneous Electrical Nerve Stimulator (RJTENS-2) receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator (RJTENS-2) received FDA 510(k) clearance on 2025-11-24, under 510(k) number K252688.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator (RJTENS-2)?

The FDA 510(k) record lists Bozhou Rongjian Medical Appliance Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator (RJTENS-2)?

The FDA product code for Transcutaneous Electrical Nerve Stimulator (RJTENS-2) is NUH.

Ensayos clínicos relacionados

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Otros registros que enlistan a Bozhou Rongjian Medical Appliance Co., Ltd. como solicitante

K220578Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)K220153Needle Stimulator (Model: RJNS6-1)K213879Self-adhesive Electrode

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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