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FDA 510(k)

Portable Electro-Stimulation Therapy Device

K-Number: K182020 · 2020-09-17

ApplicantGuangzhou Longest Science & Technology Co., Ltd.
Decision Date2020-09-17
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Portable Electro-Stimulation Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Longest Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-09-17 under 510(k) number K182020. 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 Portable Electro-Stimulation Therapy Device?

Portable Electro-Stimulation Therapy Device is a medical device that received FDA 510(k) clearance on 2020-09-17. The listed applicant is Guangzhou Longest Science & Technology Co., Ltd.. The 510(k) number is K182020.

When did Portable Electro-Stimulation Therapy Device receive FDA 510(k) clearance?

Portable Electro-Stimulation Therapy Device received FDA 510(k) clearance on 2020-09-17, under 510(k) number K182020.

Who is the listed applicant for Portable Electro-Stimulation Therapy Device?

The FDA 510(k) record lists Guangzhou Longest Science & Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Electro-Stimulation Therapy Device?

The FDA product code for Portable Electro-Stimulation Therapy Device is NGX.

Other records listing Guangzhou Longest Science & Technology Co., Ltd. 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.

K202110MStim Drop Model: LGT-233K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)K191856Compression Therapy DeviceK191862Compression Therapy Device Model LGT-2200SPK182108Portable Electro-Stimulation Therapy Device

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

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

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