Air Relax Plus Model AR-3.0 Control Unit Only

FDA UDI

Class II (US FDA UDI)

by Maxstar Industrial Co., Ltd.

Identity

Trade Name: Air Relax Plus Model AR-3.0 Control Unit Only FDA UDI
Generic Name: Sequential venous compression system inflator FDA UDI
Device Name: Air Relax Plus Model AR-3.0 Control Unit Only FDA UDI
Model / Reference: AR3 FDA UDI
Description: Air Relax Plus Model AR-3.0 Control Unit Only FDA UDI

Identifiers

Primary DI / UDI-DI: 08809040526271 FDA UDI
510(k) Number: K211460 FDA UDI
FDA Product Code: IRP FDA UDI
GMDN Term: Sequential venous compression system inflator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Sequential venous compression system inflator

Air Relax Plus Model AR-3.0 Control Unit Only by Maxstar Industrial Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sequential venous compression system inflator.

AIROS — AIROS MEDICAL INC · Class II
LF900 — DAESUNG MAREF CO., LTD. · Class II
Therabody — Therabody, Inc. · Class II
The Venous Assist System — DAESUNG MAREF CO., LTD. · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II
Bio Compression Systems Sequential Circulator Model SC-3008-IS — BIO COMPRESSION SYSTEMS, INC. · Class II
TRIPLE PLAY — Compression Solutions, LLC · Class II
Wright — Wright Therapy Products, Inc. · Class II

Cleared under the same submission

K211460 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Maxstar Industrial Co., Ltd.

Sources (1)

FDA UDI f27b47ae-1df4-466c-aa9f-dc8ed0a35d03 34 fields · synced May 30, 2026