Device Classification Name |
equipment, traction, powered
|
510(k) Number |
K112074 |
Device Name |
EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 |
Applicant |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
845 ARONSON LAKE COURT |
ROSWELL,
GA
30075
|
|
Applicant Contact |
JAY MANSOUR |
Correspondent |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
845 ARONSON LAKE COURT |
ROSWELL,
GA
30075
|
|
Correspondent Contact |
JAY MANSOUR |
Regulation Number | 890.5900
|
Classification Product Code |
|
Date Received | 07/20/2011 |
Decision Date | 02/01/2012 |
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
|
|
|