FDA 510(k)

Progenix Select Stim

K-Nummer: K242460 · 2025-04-02

Entscheidungsdatum2025-04-02

ProduktcodeNUH

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

Progenix Select Stim is the device name listed in this FDA 510(k) record. The listed applicant is Progenix, LLC. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K242460. 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 Progenix Select Stim?

Progenix Select Stim is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Progenix, LLC. The 510(k) number is K242460.

When did Progenix Select Stim receive FDA 510(k) clearance?

Progenix Select Stim received FDA 510(k) clearance on 2025-04-02, under 510(k) number K242460.

Who is the listed applicant for Progenix Select Stim?

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

What is the FDA product code for Progenix Select Stim?

The FDA product code for Progenix Select Stim 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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