Air Compression Therapy Device

GUDID 06959557200606

SHENZHEN FUTURE ELECTRONIC CO.,LTD

Multi-chamber venous compression system garment, reusable

• Primary Device ID: 06959557200606
• NIH Device Record Key: 471e66ca-73e2-4771-aefe-1cdfe3221ce1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Air Compression Therapy Device
• Version Model Number: ST-502
• 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: true
• Manufacturing Date: false
• 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	06959557200606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213745

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

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: 2022-09-14
• Device Publish Date: 2022-09-06

Devices Manufactured by SHENZHEN FUTURE ELECTRONIC CO.,LTD

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