Device Classification Name |
Lamp, Infrared, Therapeutic Heating
|
510(k) Number |
K050022 |
Device Name |
MEDX HOME |
Applicant |
MEDX ELECTRONICS, INC. |
3350 RIDGEWAY DRIVE UNIT 3 |
MISSISSAUGA ON,
CA
L5L 5Z9
|
|
Applicant Contact |
ANITA SALTMARCHE |
Correspondent |
MEDX ELECTRONICS, INC. |
3350 RIDGEWAY DRIVE UNIT 3 |
MISSISSAUGA ON,
CA
L5L 5Z9
|
|
Correspondent Contact |
ANITA SALTMARCHE |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 01/05/2005 |
Decision Date | 05/05/2005 |
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
|
|
|