510(k) K240373
K240373 is an FDA 510(k) premarket notification submitted by Zhangzhou Easepal Medical Science and Technology Co., Ltd. for the device "Air compression Leg Massager (MM0520, MM0521, MM0522)". The FDA issued a decision of Substantially Equivalent on September 17, 2024. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Zhangzhou Easepal Medical Science and Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2024
- Date Received
- February 7, 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