FDA 510(k)

Noodle

K-Nummer: K220573 · 2022-07-09

Entscheidungsdatum2022-07-09

ProduktcodeNUH

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

Noodle is the device name listed in this FDA 510(k) record. The listed applicant is Pourang Bral, Dds, LLC. It received FDA 510(k) clearance on 2022-07-09 under 510(k) number K220573. 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 Noodle?

Noodle is a medical device that received FDA 510(k) clearance on 2022-07-09. The listed applicant is Pourang Bral, Dds, LLC. The 510(k) number is K220573.

When did Noodle receive FDA 510(k) clearance?

Noodle received FDA 510(k) clearance on 2022-07-09, under 510(k) number K220573.

Who is the listed applicant for Noodle?

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

What is the FDA product code for Noodle?

The FDA product code for Noodle 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 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

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