510(k) K253150
K253150 is an FDA 510(k) premarket notification submitted by Jkh Health Co., Ltd. for the device "Cryon-X Cold Compression". The FDA issued a decision of Substantially Equivalent on October 24, 2025. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Jkh Health Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 2025
- Date Received
- September 25, 2025
- Clearance Type
- Special
- 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