FDA 510(k)

VEINOPLUS Back

K-Nummer: K251958 · 2025-12-23

Entscheidungsdatum2025-12-23

ProduktcodeNUH

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

VEINOPLUS Back is the device name listed in this FDA 510(k) record. The listed applicant is Dynapulse Medical. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K251958. 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 VEINOPLUS Back?

VEINOPLUS Back is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Dynapulse Medical. The 510(k) number is K251958.

When did VEINOPLUS Back receive FDA 510(k) clearance?

VEINOPLUS Back received FDA 510(k) clearance on 2025-12-23, under 510(k) number K251958.

Who is the listed applicant for VEINOPLUS Back?

The FDA 510(k) record lists Dynapulse Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VEINOPLUS Back?

The FDA product code for VEINOPLUS Back is NUH.

Zugehörige klinische Studien

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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 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

Offizielle Quelle

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