510(k) K102938
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