510(k) K140592
K140592 is an FDA 510(k) premarket notification submitted by Ceragem International, Inc. for the device "CERAGEM AUTOMATIC THERMAL MASSAGER". The FDA issued a decision of Substantially Equivalent on December 17, 2014. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880. Ceragem International, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2014
- Date Received
- March 7, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Physical Therapy, Multi Function
- Device Class
- Class II
- Regulation Number
- 890.5880
- Review Panel
- PM
- Submission Type