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FDA 510(k)

Portable Electro-Stimulation Therapy Device

K-Number: K182108 · 2019-04-26

ApplicantGuangzhou Longest Science & Technology Co., Ltd.
Decision Date2019-04-26
Product CodeNUH
Advisory CommitteeNE
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 2019-04-26 under 510(k) number K182108. 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 Portable Electro-Stimulation Therapy Device?

Portable Electro-Stimulation Therapy Device is a medical device that received FDA 510(k) clearance on 2019-04-26. The listed applicant is Guangzhou Longest Science & Technology Co., Ltd.. The 510(k) number is K182108.

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

Portable Electro-Stimulation Therapy Device received FDA 510(k) clearance on 2019-04-26, under 510(k) number K182108.

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 NUH.

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)K182020Portable Electro-Stimulation Therapy DeviceK191856Compression Therapy DeviceK191862Compression Therapy Device Model LGT-2200SP

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

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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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