Device Classification Name |
lamp, infrared, therapeutic heating
|
510(k) Number |
K051816 |
Device Name |
LUMIWAVE 1X4 INFRARED THERAPY DEVICE |
Applicant |
BIOCARE SYSTEMS, INC. |
518 17TH STREET |
SUITE 1350 |
DENVER,
CO
80202
|
|
Applicant Contact |
CLAY ANSELMO |
Correspondent |
BIOCARE SYSTEMS, INC. |
518 17TH STREET |
SUITE 1350 |
DENVER,
CO
80202
|
|
Correspondent Contact |
CLAY ANSELMO |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 07/05/2005 |
Decision Date | 08/26/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|