Electronic Stimulator

GUDID 06974700021020

Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.

Shenzhen Leqing Medical Instrument Co., LTD

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06974700021020
• NIH Device Record Key: 76c0f5fe-3fe2-4282-a0ac-5be13b3a6df5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electronic Stimulator
• Version Model Number: uNeck-9517B
• Company DUNS: 710753231
• Company Name: Shenzhen Leqing Medical Instrument 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974700021020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223428

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-25
• Device Publish Date: 2023-05-17

On-Brand Devices [Electronic Stimulator]

• 06974700021129: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 06974700021112: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 06974700021105: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 06974700021099: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 06974700021082: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 06974700021075: Electrical simulation: To be used for temporary relief of pain associated with sore and aching m
• 06974700021068: Electrical simulation: To be used for temporary relief of pain associated with sore and aching m
• 06974700021051: Electrical simulation: To be used for temporary relief of pain associated with sore and aching m
• 06974700021044: Electrical simulation: To be used for temporary relief of pain associated with sore and aching m
• 06974700021037: Electrical simulation: To be used for temporary relief of pain associated with sore and aching m
• 06974700021020: Electrical simulation: To be used for temporary relief of pain associated with sore and aching m
• 06974700021013: Electrical simulation: To be used for temporary relief of pain associated with sore and aching m
• 06974700021006: Electrical simulation: To be used for temporary relief of pain associated with sore and aching m