Air compression leg massager— 510(k) K240981

Name: FDA 510(k) clearance K240981
Creator: U.S. Food and Drug Administration
Published: 2024-08-02

Substantially Equivalent

Huizhou Xinyi Technology Co., Ltd.

FDA 510(k) clearance K240981 for Air compression leg massager, Substantially Equivalent on 2024-08-02. Applicant: Huizhou Xinyi Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Huizhou Xinyi Technology Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2024-04-10
Decision date: 2024-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huizhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code IRP

view all

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 Huizhou Xinyi Technology Co., Ltd.

view all

K221862 — YY-A02-B Overlapped Compression Therapy2022-12-08

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