Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K220601 |
Device Name |
CoolTone |
Applicant |
Zimmer MedizinSysteme GmbH |
Junkersstrasse 9 |
Neu-Ulm,
DE
89231
|
|
Applicant Contact |
Julia Kredler |
Correspondent |
Quality and Regulatory Services |
151 Glensondale Road |
Stow,
MA
01775
|
|
Correspondent Contact |
Scott Blood |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 03/02/2022 |
Decision Date | 04/01/2022 |
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
|
|
|