Device Classification Name |
vibrator, therapeutic
|
510(k) Number |
K934886 |
Device Name |
NEXT WAVE PHYSIOACOUSTIC MATTRESS |
Applicant |
NEXT WAVE, INC. |
5555 GULL ROAD, SUITE 103 |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
ROLAND H POTRYKUS |
Correspondent |
NEXT WAVE, INC. |
5555 GULL ROAD, SUITE 103 |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
ROLAND H POTRYKUS |
Regulation Number | 890.5975
|
Classification Product Code |
|
Date Received | 10/12/1993 |
Decision Date | 06/09/1994 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|