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FDA 510(k)

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

K-Number: K220283 · 2022-05-02

ApplicantHong Qiangxing (Shenzhen) Electronics Limited
Decision Date2022-05-02
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Hong Qiangxing (Shenzhen) Electronics Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)K220152TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)K220150TENS & PMS (Model: SM9126)K201354TENS & PMSK190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)K183154SM Electrodes

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Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 LimitedK251958VEINOPLUS BackDynapulse Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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