510(k) K031996
K031996 is an FDA 510(k) premarket notification submitted by Advanced Back Technologies for the device "EXTENTRAC ELITE". The FDA issued a decision of Substantially Equivalent on July 23, 2004. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Advanced Back Technologies has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2004
- Date Received
- June 27, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Equipment, Traction, Powered
- Device Class
- Class II
- Regulation Number
- 890.5900
- Review Panel
- PM
- Submission Type