Air Relax Classic Model AR-2.0 Leg Recovery System - Size 2

GUDID 08809040527018

Air Relax Classic Model AR-2.0 Leg Recovery System - Size 2 (110V US PLUG - With Bag)

Maxstar Industrial Co.,Ltd.

Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump

• Primary Device ID: 08809040527018
• NIH Device Record Key: 13547e44-bd59-4dfc-9b92-1f784316be0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Air Relax Classic Model AR-2.0 Leg Recovery System - Size 2
• Version Model Number: AR2-S2-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	08809040527018 [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 2]

• 08809040526820: Air Relax Classic Model AR-2.0 Leg Recovery System - Size 2 (110V US PLUG - TYPE A)
• 08809040527018: Air Relax Classic Model AR-2.0 Leg Recovery System - Size 2 (110V US PLUG - With Bag)