Transcutaneous Electrical Nerve Stimulator

GUDID 06959557200354

SHENZHEN FUTURE ELECTRONIC CO.,LTD

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06959557200354
• NIH Device Record Key: 1e318cda-f5b9-45f1-aa36-a18c08ec355c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transcutaneous Electrical Nerve Stimulator
• Version Model Number: ST-304
• Company DUNS: 528197534
• Company Name: SHENZHEN FUTURE ELECTRONIC 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: false
• 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	06959557200354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221092

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: 2022-10-10
• Device Publish Date: 2022-09-30

Devices Manufactured by SHENZHEN FUTURE ELECTRONIC CO.,LTD

• 06959557200354 - Transcutaneous Electrical Nerve Stimulator: 2022-10-10
• 06959557200354 - Transcutaneous Electrical Nerve Stimulator: 2022-10-10
• 06959557200606 - Air Compression Therapy Device: 2022-09-14