Transcutaneous Electrical Nerve Stimulator

GUDID 06959557200354

SHENZHEN FUTURE ELECTRONIC 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 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 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