Device Classification Name |
stimulator, transcutaneous electrical, aesthetic purposes
|
510(k) Number |
K232001 |
Device Name |
Nu Skin RenuSpa iO |
Applicant |
NSE Products, Inc |
75 West Center Street |
Provo,
UT
84601 4432
|
|
Applicant Contact |
McKay Noll |
Correspondent |
Methodize Inc. |
24813 Cty 18 |
Nevis,
MN
56467
|
|
Correspondent Contact |
Jack Slovick |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 07/05/2023 |
Decision Date | 11/21/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|