Air Compression Massager (EP30B001 I)— 510(k) K260948
Substantially EquivalentWavepulse (Xiamen) Healthcare Technology Co., Ltd.
FDA 510(k) clearance K260948 for Air Compression Massager (EP30B001 I), Substantially Equivalent on 2026-07-24. Applicant: Wavepulse (Xiamen) Healthcare Technology Co., Ltd.. Device class: 2.
Summary
Wavepulse (Xiamen) Healthcare Technology's Air Compression Massager (EP30B001 I) is filed under IRP, powered inflatable tube massagers. The record gives the model as EP30B001 I but no specs.
Class II, 21 CFR 890.5650. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Wavepulse filed from Xiamen, China. Review took 123 calendar days (March 23 to July 24, 2026).
Clearance details
- Applicant
- Wavepulse (Xiamen) Healthcare 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)
- K253919 — Cryo And Thermo Therapy System
Data sourced from openFDA. This site is unofficial and independent of the FDA.