FDA 510(k)

TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)

Numéro K : K220283 · 2022-05-02

DemandeurHong Qiangxing (Shenzhen) Electronics Limited

Date de décision2022-05-02

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) 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 2022-05-02 under 510(k) number K220283. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)?

TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) is a medical device that received FDA 510(k) clearance on 2022-05-02. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K220283.

When did TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) receive FDA 510(k) clearance?

TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) received FDA 510(k) clearance on 2022-05-02, under 510(k) number K220283.

Who is the listed applicant for TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)?

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 TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)?

The FDA product code for TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) is NUH.

Essais cliniques associés

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Autres dossiers indiquant Hong Qiangxing (Shenzhen) Electronics Limited en tant que demandeur

K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)K220152TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)K220150TENS & PMS (Model: SM9126)K201354TENS & PMS K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)K183154SM Electrodes

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Dispositifs connexes (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

Source officielle

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