Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K160052 |
Device Name |
CUR Model 1 |
Applicant |
Thimble Bioelectronics, Inc. |
2011 26th St. Ste. 202 |
San Francisco,
CA
94107
|
|
Applicant Contact |
Shaun Rahimi |
Correspondent |
Thimble Bioelectronics, Inc. |
2011 26th St. Ste. 202 |
San Francisco,
CA
94107
|
|
Correspondent Contact |
Shaun Rahimi |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/11/2016 |
Decision Date | 05/20/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|