FDA 510(k)

AD-2126 Estimuladores Nervosos Transcutâneos (TENS)

Número K: K222867 · 2022-12-21

Data da decisão2022-12-21

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K222867. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)?

AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K222867.

When did AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) receive FDA 510(k) clearance?

AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) received FDA 510(k) clearance on 2022-12-21, under 510(k) number K222867.

Who is the listed applicant for AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)?

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

What is the FDA product code for AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)?

The FDA product code for AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) 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

Fonte oficial

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