Device Classification Name |
Lamp, Infrared, Therapeutic Heating
|
510(k) Number |
K060134 |
Device Name |
APOLLO IR HEAT LAMP SYSTEM |
Applicant |
APOLLO PHYSICAL THERAPY PRODUCTS INTERNATIONAL |
12101 CULLEN BLVD. |
SUITE A |
HOUSTON,
TX
77047
|
|
Applicant Contact |
M. JOYCE HEINRICH |
Correspondent |
APOLLO PHYSICAL THERAPY PRODUCTS INTERNATIONAL |
12101 CULLEN BLVD. |
SUITE A |
HOUSTON,
TX
77047
|
|
Correspondent Contact |
M. JOYCE HEINRICH |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 01/18/2006 |
Decision Date | 03/21/2006 |
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
|
Recalls |
CDRH Recalls
|
|
|