Air Relax Classic Model AR-2.0 Leg Recovery System - Size 3

GUDID 08809040527025

Air Relax Classic Model AR-2.0 Leg Recovery System - Size 3 (110V US PLUG - With Bag)

Maxstar Industrial Co.,Ltd.

Sequential venous compression system pump

• Primary Device ID: 08809040527025
• NIH Device Record Key: a508f6ce-286d-46b9-82ca-dd31959fdfa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Air Relax Classic Model AR-2.0 Leg Recovery System - Size 3
• Version Model Number: AR2-S3-CB1
• Company DUNS: 687844027
• Company Name: Maxstar Industrial 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: false
• 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	08809040527025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191441

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: 2022-04-04
• Device Publish Date: 2022-03-25

On-Brand Devices [Air Relax Classic Model AR-2.0 Leg Recovery System - Size 3]

• 08809040526837: Air Relax Classic Model AR-2.0 Leg Recovery System - Size 3 (110V US PLUG - TYPE A)
• 08809040527025: Air Relax Classic Model AR-2.0 Leg Recovery System - Size 3 (110V US PLUG - With Bag)