Device Classification Name |
Lamp, Infrared, Therapeutic Heating
|
510(k) Number |
K051046 |
Device Name |
PAINACEA MODEL XR8 INFRARED HEAT LAMP |
Applicant |
ATLANTIS LUMINESCENT PRODUCTS, LLC |
11874 SOUTH EVELYN CIRCLE |
HOUSTON,
TX
77071
|
|
Applicant Contact |
JAMES HARVEY KNAUSS |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 04/25/2005 |
Decision Date | 05/10/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|