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Air Relax 8100N

by Maxstar Industrial Co., Ltd.

Air Relax 8100N is a sequential venous compression system inflator (FDA Class II; FDA product code IRP, Massager, Powered Inflatable Tube) made by Maxstar Industrial Co., Ltd., cleared under FDA 510(k) K173158 on 30 May 2019 and listed in FDA GUDID since 27 Apr 2026 (UDI-DI 08809040526691), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K173158

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809040526691 UDI-DI Date27 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK173158 Date30 May 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173158 decided 30 May 2019 Active
  • FDA GUDID UDI-DI 08809040526691 listed 27 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173158
  2. Listed FDA GUDID 08809040526691

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Air Relax
Generic name
Sequential venous compression system inflator
Model / reference
8100N
Primary DI / UDI-DI
08809040526691
510(k) Number
FDA product code
IRP
GMDN term
Sequential venous compression system inflator
Device class
Class II
Regulation number
890.5650
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K173158)

Similar devices

Other devices filed under FDA product code IRP (Massager, Powered Inflatable Tube).

Other devices from Maxstar Industrial Co., Ltd.

See all devices from Maxstar Industrial Co., Ltd. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)