Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K150386 |
FOIA Releasable 510(k) |
K150386
|
Device Name |
Tyece OTC TENS Device |
Applicant |
TYECE LTD |
Unit 801, Block A, Po Lung Centre, 11 Wang Chiu Rd., |
Kowloon Bay |
Kowloon, Hong Kong,
HK
|
|
Applicant Contact |
Parshid Falahati |
Correspondent |
MEDIA TRADE CORPORATION |
11820 RED HIBISCUS DRIVE |
BONITA SPRINGS,
FL
34135
|
|
Correspondent Contact |
Guenter Ginsberg |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 02/18/2015 |
Decision Date | 11/05/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|