510(k) K260948
K260948 is an FDA 510(k) premarket notification submitted by Wavepulse (Xiamen) Healthcare Technology Co., Ltd. for the device "Air Compression Massager (EP30B001 I)". The FDA issued a decision of Substantially Equivalent on July 24, 2026. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2026
- Date Received
- March 23, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Powered Inflatable Tube
- Device Class
- Class II
- Regulation Number
- 890.5650
- Review Panel
- PM
- Submission Type