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Air Relax Plus Model AR-3.0 Leg Recovery System - Size 2
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Air Relax Plus Model AR-3.0 Leg Recovery System - Size 2 FDA UDI
- Generic Name
- Sequential venous compression system inflator FDA UDI
- Device Name
- Air Relax Plus Model AR-3.0 Leg Recovery System - Size 2 FDA UDI
- Model / Reference
- AR3-S2 FDA UDI
- Description
- Air Relax Plus Model AR-3.0 Leg Recovery System - Size 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809040526387 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sequential venous compression system inflator
Air Relax Plus Model AR-3.0 Leg Recovery System - Size 2 by Maxstar Industrial Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
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:
- Air Relax Plus Model AR-3.0 & AR-2.0 Arm Sleeve - Size 1 — Maxstar Industrial Co., Ltd.
- Air Relax Plus Model AR-3.0 & AR-2.0 Arm Sleeve - Size 2 — Maxstar Industrial Co., Ltd.
- Air Relax Plus Model AR-3.0 & AR-2.0 Leg Sleeve Extenders - Size 3 — Maxstar Industrial Co., Ltd.
- Air Relax Plus Model AR-3.0 & AR-2.0 Leg Sleeve Extenders - Size 4 — Maxstar Industrial Co., Ltd.
- Air Relax Plus Model AR-3.0 & AR-2.0 Leg Sleeve Extenders- Size 2 — Maxstar Industrial Co., Ltd.
- Air Relax Plus Model AR-3.0 & AR-2.0 Leg Sleeves - Size 2 — Maxstar Industrial Co., Ltd.
- Air Relax Plus Model AR-3.0 & AR-2.0 Leg Sleeves - Size 3 — Maxstar Industrial Co., Ltd.
- Air Relax Plus Model AR-3.0 & AR-2.0 Leg Sleeves - Size 4 — Maxstar Industrial Co., Ltd.
- Air Relax Plus Model AR-3.0 & AR-2.0 Shorts - Size 1 — Maxstar Industrial Co., Ltd.
- Air Relax Plus Model AR-3.0 & AR-2.0 Shorts - Size 2 — Maxstar Industrial Co., Ltd.
- Air Relax Plus Model AR-3.0 Control Unit Only — Maxstar Industrial Co., Ltd.
- Air Relax Plus Model AR-3.0 Leg Recovery System - Size 3 — Maxstar Industrial Co., Ltd.
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 486aea45-b0ec-494f-8adc-32738e94d592 34 fields · synced May 30, 2026