Device
AIR RELAX MODEL UAM-8100N LEG RECOVERY SYSTEM - SIZE 3
Manufacturer
Maxstar Industrial Co.,Ltd.
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