510(k) K102281

THERMAL MASSAGE BED, MODEL 2D-GX by Inarex Corporation — Product Code JFB

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