Air Pressure Therapy System (3 models)— 510(k) K253064

Name: FDA 510(k) clearance K253064
Creator: U.S. Food and Drug Administration
Published: 2026-04-30

Substantially Equivalent

Xiamen Weiyou Intelligent Technology Co., Ltd.

FDA 510(k) clearance K253064 for Air Pressure Therapy System (3 models), Substantially Equivalent on 2026-04-30. Applicant: Xiamen Weiyou Intelligent Technology Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X)
Applicant: Xiamen Weiyou Intelligent Technology Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2025-09-22
Decision date: 2026-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiamen, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Xiamen Weiyou Intelligent Technology Co., Ltd.

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K243791 — Air Pressure Therapy System2025-01-13
K243320 — Air Pressure Therapy System (VU-IPC04B)2024-11-18
K233238 — Air Pressure Therapy System (Model:VU-IPC4M)2024-06-14
K201935 — Air Pressure Therapy System2021-06-22
K210967 — Air Pressure Therapy System: VU-IPC062021-05-11

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