510(k) K242140
K242140 is an FDA 510(k) premarket notification submitted by Jiale Health Technology Shenzhen Co., Ltd. for the device "Air Compression Leg Massager (K-705)". The FDA issued a decision of Substantially Equivalent on March 17, 2025. 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
- March 17, 2025
- Date Received
- July 22, 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