FDA 510(k)

TENS 7000 Rechargeable 4 Channel (TENS 7000H)

K-Nummer: K260412 · 2026-06-26

AntragstellerShenzhen Dongdixin Technology Co., Ltd.

Entscheidungsdatum2026-06-26

ProduktcodeNUH

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

TENS 7000 Rechargeable 4 Channel (TENS 7000H) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-26 under 510(k) number K260412. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the TENS 7000 Rechargeable 4 Channel (TENS 7000H)?

TENS 7000 Rechargeable 4 Channel (TENS 7000H) is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K260412.

When did TENS 7000 Rechargeable 4 Channel (TENS 7000H) receive FDA 510(k) clearance?

TENS 7000 Rechargeable 4 Channel (TENS 7000H) received FDA 510(k) clearance on 2026-06-26, under 510(k) number K260412.

Who is the listed applicant for TENS 7000 Rechargeable 4 Channel (TENS 7000H)?

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

What is the FDA product code for TENS 7000 Rechargeable 4 Channel (TENS 7000H)?

The FDA product code for TENS 7000 Rechargeable 4 Channel (TENS 7000H) is NUH.

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Verwandte Geräte (Code: 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 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 K251958VEINOPLUS BackDynapulse Medical

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