510(k) K102281
K102281 is an FDA 510(k) premarket notification submitted by Inarex Corporation for the device "THERMAL MASSAGE BED, MODEL 2D-GX". The FDA issued a decision of Substantially Equivalent on December 22, 2010. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880. Inarex Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2010
- Date Received
- August 11, 2010
- Clearance Type
- Special
- 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