Device Classification Name |
Equipment, Traction, Powered
|
510(k) Number |
K042482 |
Device Name |
BASS ANTALGIC-TRAK |
Applicant |
TRACTION MASTERS, L.L.C. |
9737 NW 65TH WAY |
PARKLAND,
FL
33076
|
|
Applicant Contact |
DAVID B BASS |
Correspondent |
TRACTION MASTERS, L.L.C. |
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
|
|
|