Device Classification Name |
massager, vacuum, radio frequency induced heat
|
510(k) Number |
K181893 |
Device Name |
T-PLUS |
Applicant |
Wintecare SA |
Via Livio 12 |
Chiasso,
CH
6830
|
|
Applicant Contact |
Claudio Freti |
Correspondent |
Wintecare SA |
Via Livio 12 |
Chiasso,
CH
6830
|
|
Correspondent Contact |
Claudio Freti |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 07/13/2018 |
Decision Date | 01/29/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|