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FDA 510(k)

TENS & PMS

K-Number: K201354 · 2020-12-11

ApplicantHong Qiangxing (Shenzhen) Electronics Limited
Decision Date2020-12-11
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TENS & PMS 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 2020-12-11 under 510(k) number K201354. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENS & PMS?

TENS & PMS is a medical device that received FDA 510(k) clearance on 2020-12-11. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K201354.

When did TENS & PMS receive FDA 510(k) clearance?

TENS & PMS received FDA 510(k) clearance on 2020-12-11, under 510(k) number K201354.

Who is the listed applicant for TENS & PMS?

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?

The FDA product code for TENS & PMS is NGX.

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)K220283TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)K220152TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)K220150TENS & PMS (Model: SM9126)K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)K183154SM Electrodes

View all 7 devices →

Related Devices (Code: NGX)

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.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

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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