Air Relax Pro Model AR-4.0 Arm Sleeves - Size 1

GUDID 08809040526530

Air Relax Pro Model AR-4.0 Arm Sleeves - Size 1

Maxstar Industrial Co.,Ltd.

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• Primary Device ID: 08809040526530
• NIH Device Record Key: 343d499f-401c-4fa7-ab6b-0e8e6046ca4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Air Relax Pro Model AR-4.0 Arm Sleeves - Size 1
• Version Model Number: AR4-AS-S1
• 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	08809040526530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212491

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: 2023-02-16
• Device Publish Date: 2023-02-08

Devices Manufactured by Maxstar Industrial Co.,Ltd.

• 08809040526462 - Air Relax Pro Model AR-4.0 Control Unit Only: 2023-02-16 Air Relax Pro Model AR-4.0 Control Unit Only
• 08809040526479 - Air Relax Pro Model AR-4.0 Leg Recovery System with a Carrying Case - Size 2: 2023-02-16 Air Relax Pro Model AR-4.0 Leg Recovery System with a Carrying Case - Size 2
• 08809040526486 - Air Relax Pro Model AR-4.0 Leg Recovery System with a Carrying Case - Size 3: 2023-02-16 Air Relax Pro Model AR-4.0 Leg Recovery System with a Carrying Case - Size 3
• 08809040526493 - Air Relax Pro Model AR-4.0 Leg Recovery System with a Carrying Case - Size 4: 2023-02-16 Air Relax Pro Model AR-4.0 Leg Recovery System with a Carrying Case - Size 4
• 08809040526509 - Air Relax Pro Model AR-4.0 Leg Sleeves - Size 2: 2023-02-16 Air Relax Pro Model AR-4.0 Leg Sleeves - Size 2
• 08809040526516 - Air Relax Pro Model AR-4.0 Leg Sleeves - Size 3: 2023-02-16 Air Relax Pro Model AR-4.0 Leg Sleeves - Size 3
• 08809040526523 - Air Relax Pro Model AR-4.0 Leg Sleeves - Size 4: 2023-02-16 Air Relax Pro Model AR-4.0 Leg Sleeves - Size 4
• 08809040526530 - Air Relax Pro Model AR-4.0 Arm Sleeves - Size 1: 2023-02-16Air Relax Pro Model AR-4.0 Arm Sleeves - Size 1
• 08809040526530 - Air Relax Pro Model AR-4.0 Arm Sleeves - Size 1: 2023-02-16 Air Relax Pro Model AR-4.0 Arm Sleeves - Size 1