510(k) K240981
K240981 is an FDA 510(k) premarket notification submitted by Huizhou Xinyi Technology Co., Ltd. for the device "Air compression leg massager". The FDA issued a decision of Substantially Equivalent on August 2, 2024. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Huizhou Xinyi Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2024
- Date Received
- April 10, 2024
- 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