Advanced Back Technologies, Inc.

FDA Regulatory Profile

Advanced Back Technologies, Inc. appears in FDA public data with 2 recalls, 2 510(k) clearances, 8 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1717-2015, Class II) was initiated on May 13, 2015. Its most recent 510(k) clearance was granted on July 23, 2004.

Summary

Total Recalls
2
510(k) Clearances
2
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1717-2015Class IIExtentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)May 13, 2015
Z-1718-2015Class IIExtentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)May 13, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K031996EXTENTRAC ELITEJuly 23, 2004
K980021EXTENTRACMay 11, 1998