| Device Classification Name |
Equipment, Traction, Powered
|
| 510(k) Number |
K042482 |
| Device Name |
BASS ANTALGIC-TRAK |
| Applicant |
| Traction Masters, LLC |
| 9737 NW 65th Way |
|
Parkland,
FL
33076
|
|
| Applicant Contact |
DAVID B BASS |
| Correspondent |
| Traction Masters, LLC |
| 9737 NW 65th Way |
|
Parkland,
FL
33076
|
|
| Correspondent Contact |
DAVID B BASS |
| Regulation Number | 890.5900 |
| Classification Product Code |
|
| Date Received | 09/13/2004 |
| Decision Date | 03/21/2005 |
| 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
|
|
|