Air Relax— 510(k) K173158

Substantially Equivalent

Maxstar Industrial Co., Ltd.

FDA 510(k) clearance K173158 for Air Relax, Substantially Equivalent on 2019-05-30. Applicant: Maxstar Industrial Co., Ltd.. Device class: 2.

Clearance details

Applicant: Maxstar Industrial Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2017-09-29
Decision date: 2019-05-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Gimpo, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code IRP

K260944 — ManaCold Compression System2026-08-12
K260529 — Air Compression Massager (HY-1165)2026-07-27
K260948 — Air Compression Massager (EP30B001 I)2026-07-24
K253919 — Cryo And Thermo Therapy System2026-06-10
K252396 — Cryo Sport 2.0 (AVA 501)2026-05-29

More clearances from Maxstar Industrial Co., Ltd.

Data sourced from openFDA. This site is unofficial and independent of the FDA.