510(k) K193550
K193550 is an FDA 510(k) premarket notification submitted by Zenith Technical Innovations for the device "Therm-X". The FDA issued a decision of Substantially Equivalent on February 28, 2020. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Zenith Technical Innovations has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2020
- Date Received
- December 20, 2019
- 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