FDA 510(k)

S21 OTC Transcutaneous Electrical Nerve Stimulator

N.º K: K233095 · 2024-03-01

SolicitanteMicro Current Technology, Inc.

Fecha de decisión2024-03-01

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

S21 OTC Transcutaneous Electrical Nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Micro Current Technology, Inc.. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K233095. 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 S21 OTC Transcutaneous Electrical Nerve Stimulator?

S21 OTC Transcutaneous Electrical Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Micro Current Technology, Inc.. The 510(k) number is K233095.

When did S21 OTC Transcutaneous Electrical Nerve Stimulator receive FDA 510(k) clearance?

S21 OTC Transcutaneous Electrical Nerve Stimulator received FDA 510(k) clearance on 2024-03-01, under 510(k) number K233095.

Who is the listed applicant for S21 OTC Transcutaneous Electrical Nerve Stimulator?

The FDA 510(k) record lists Micro Current Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S21 OTC Transcutaneous Electrical Nerve Stimulator?

The FDA product code for S21 OTC Transcutaneous Electrical Nerve Stimulator is NUH.

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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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