Air Pressure Therapy System (3 models)— 510(k) K253064
Substantially EquivalentXiamen 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.
Summary
Xiamen Weiyou Intelligent Technology lists three Air Pressure Therapy System models in this record: VU-IPC8M, VU-IPC6M, and VU-IPC4X. All three are filed under product code IRP (Massager, Powered Inflatable Tube).
Class II, 21 CFR 890.5650. Physical Medicine is both the classification panel and the review panel. It came in as a Traditional 510(k).
Xiamen Weiyou filed from Xiamen, China. The record shows 220 calendar days from receipt to decision (September 22, 2025 to April 30, 2026).
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
- Product code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Xiamen, CN
Recent devices under product code IRP
view all- K261887 — Normatec Elite Heat (6 models)
- K262812 — Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)
- K260944 — ManaCold Compression System
- K260529 — Air Compression Massager (HY-1165)
- K260948 — Air Compression Massager (EP30B001 I)
More clearances from Xiamen Weiyou Intelligent Technology Co., Ltd.
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