Device Classification Name |
interferential current therapy
|
510(k) Number |
K052289 |
FOIA Releasable 510(k) |
K052289
|
Device Name |
DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE |
Applicant |
BIOWAVE CORPORATION |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
MARY MCNAMARA-CULLINANE |
Correspondent |
BIOWAVE CORPORATION |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
MARY MCNAMARA-CULLINANE |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 08/23/2005 |
Decision Date | 12/13/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|