Portable Electro-Stimulation Therapy Device

GUDID 06971410780032

Guangzhou Longest Science & Technology Co., Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06971410780032
• NIH Device Record Key: eea6e280-52fb-4e7b-8f2c-1790659a3a33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portable Electro-Stimulation Therapy Device
• Version Model Number: LGT-232(US)
• Company DUNS: 527141843
• Company Name: Guangzhou Longest Science & Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971410780032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201845

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-19
• Device Publish Date: 2020-11-06

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

• 06971410780049: LGT-235(US)
• 06971410780025: LGT-231(US)
• 06971410780032: LGT-232(US)
• 06971410780063: LGT-233