Portable Electro-Stimulation Therapy Device

GUDID 06971410780025

Guangzhou Longest Science & Technology Co., Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID06971410780025
NIH Device Record Key1114bb09-6db9-472c-81b1-42b1d25faf83
Commercial Distribution StatusIn Commercial Distribution
Brand NamePortable Electro-Stimulation Therapy Device
Version Model NumberLGT-231(US)
Company DUNS527141843
Company NameGuangzhou Longest Science & Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106971410780025 [Primary]
GS106971410780025 [Primary]
GS106971410780025 [Primary]
GS106971410780025 [Primary]
GS106971410780025 [Primary]
GS106971410780025 [Primary]
GS106971410780025 [Primary]
GS106971410780025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NYNStimulator, Electrical, Transcutaneous, For Arthritis
NYNStimulator, Electrical, Transcutaneous, For Arthritis
NYNStimulator, Electrical, Transcutaneous, For Arthritis
NYNStimulator, Electrical, Transcutaneous, For Arthritis
NYNStimulator, Electrical, Transcutaneous, For Arthritis
NYNStimulator, Electrical, Transcutaneous, For Arthritis
NYNStimulator, Electrical, Transcutaneous, For Arthritis
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [Portable Electro-Stimulation Therapy Device]

06971410780049LGT-235(US)
06971410780025LGT-231(US)

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