| Device Classification Name |
Equipment, Traction, Powered
|
| 510(k) Number |
K053223 |
| Device Name |
TRITON/TRU-TRAC/TX/TRITON DTS TRACTION |
| Applicant |
| Chattanooga Group |
| 4717 Adams Rd. |
| P.O. Box 489 |
|
Hixson,
TN
37343
|
|
| Applicant Contact |
MICHAEL TREAS |
| Correspondent |
| Chattanooga Group |
| 4717 Adams Rd. |
| P.O. Box 489 |
|
Hixson,
TN
37343
|
|
| Correspondent Contact |
MICHAEL TREAS |
| Regulation Number | 890.5900 |
| Classification Product Code |
|
| Date Received | 11/17/2005 |
| Decision Date | 02/24/2006 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|