510(k) K102938

ACQPOINT THERMAJADE MASSAGE TABLE by Acqpoint, Inc. — Product Code JFB

K102938 is an FDA 510(k) premarket notification submitted by Acqpoint, Inc. for the device "ACQPOINT THERMAJADE MASSAGE TABLE". The FDA issued a decision of Substantially Equivalent on September 23, 2011. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2011
Date Received
October 4, 2010
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