Device Classification Name |
Equipment, Traction, Powered
|
510(k) Number |
K031996 |
Device Name |
EXTENTRAC ELITE |
Applicant |
ADVANCED BACK TECHNOLOGIES |
227 JACKSON AVE. |
SYOSSET,
NY
11791
|
|
Applicant Contact |
DAVID F CUCCIA |
Correspondent |
ADVANCED BACK TECHNOLOGIES |
227 JACKSON AVE. |
SYOSSET,
NY
11791
|
|
Correspondent Contact |
DAVID F CUCCIA |
Regulation Number | 890.5900
|
Classification Product Code |
|
Date Received | 06/27/2003 |
Decision Date | 07/23/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|