FDA 510(k)

Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01

K-Nummer: K212377 · 2022-04-15

AntragstellerNingbo Medkinetic Medical Device Co., Ltd.

Entscheidungsdatum2022-04-15

ProduktcodeNUH

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Medkinetic Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-04-15 under 510(k) number K212377. 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 Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01?

Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 is a medical device that received FDA 510(k) clearance on 2022-04-15. The listed applicant is Ningbo Medkinetic Medical Device Co., Ltd.. The 510(k) number is K212377.

When did Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 receive FDA 510(k) clearance?

Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 received FDA 510(k) clearance on 2022-04-15, under 510(k) number K212377.

Who is the listed applicant for Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01?

The FDA 510(k) record lists Ningbo Medkinetic Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01?

The FDA product code for Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 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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