Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K181199 |
Device Name |
Katalyst Mark 1 Muscle Stimulation System Model 2 |
Applicant |
Katalyst Inc. |
316 Occidental Ave. |
South Suite B300 |
Seattle,
WA
98104
|
|
Applicant Contact |
Bjoern Woltermann |
Correspondent |
Katalyst Inc. |
316 Occidental Ave. |
South Suite B300 |
Seattle,
WA
98104
|
|
Correspondent Contact |
Bjoern Woltermann |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 05/07/2018 |
Decision Date | 09/20/2018 |
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
|
|
|