510(k) K240125
K240125 is an FDA 510(k) premarket notification submitted by Zenith Technical Innovations for the device "Therm-X (Home); Therm-X (AT)". The FDA issued a decision of Substantially Equivalent on June 21, 2024. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Zenith Technical Innovations has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 2024
- Date Received
- January 16, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type