Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K192940 |
Device Name |
CoolTone |
Applicant |
Zimmer MedizinSysteme GmbH |
Junkerstrasse 9 |
Neu-Ulm,
DE
89231
|
|
Applicant Contact |
Ute Hauss |
Correspondent |
Quality and Regulatory Services |
151 Glensondale Road |
Stow,
MA
01775
|
|
Correspondent Contact |
Scott Blood |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 10/18/2019 |
Decision Date | 11/15/2019 |
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
|
|
|