FDA 510(k)

Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)

K-Nummer: K190009 · 2019-12-02

AntragstellerHong Qiangxing (Shenzhen) Electronics Limited

Entscheidungsdatum2019-12-02

ProduktcodeNUH

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) is the device name listed in this FDA 510(k) record. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2019-12-02 under 510(k) number K190009. 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 Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)?

Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) is a medical device that received FDA 510(k) clearance on 2019-12-02. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K190009.

When did Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) receive FDA 510(k) clearance?

Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) received FDA 510(k) clearance on 2019-12-02, under 510(k) number K190009.

Who is the listed applicant for Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)?

The FDA 510(k) record lists Hong Qiangxing (Shenzhen) Electronics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)?

The FDA product code for Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) is NUH.

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Weitere Einträge mit Hong Qiangxing (Shenzhen) Electronics Limited als Antragsteller

K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)K220283TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)K220152TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)K220150TENS & PMS (Model: SM9126)K201354TENS & PMS K183154SM Electrodes

Alle 7 Geräte anzeigen →

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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