Device
AIR RELAX MODEL UAM-8100N LEG RECOVERY SYSTEM - SIZE 3
Manufacturer
Maxstar Industrial Co.,Ltd.
Model: 8100N-S3 DI: 08809040526714 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-27 Current Version: 2026-05-05
Description
AIR RELAX MODEL UAM-8100N LEG RECOVERY SYSTEM - SIZE 3
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 5e265021-ffe2-4c70-a298-574ecca24255
Distribution Status: In Commercial Distribution
DUNS Number: 687844027
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: Yes
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 08809040526714
Type: Primary
Issuing Agency: GS1
GMDN
Code: 44785
Name: Sequential venous compression system inflator
Definition:
An electrically-powered device intended to be used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit applied to the extremities with the necessary pressure to promote venous blood flow through its sequential inflation and deflation. Also referred to as a pump, it typically consists of a compressor with advanced control/timing mechanism, pressure limiting device, tubing, and connectors. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk.
FDA Product Codes
IRP
Massager, Powered Inflatable Tube
Premarket Submissions
Submission Number: K173158
Supplement Number: 000