Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K240292 |
Device Name |
Transcutaneous Electrical Nerve Stimulator (9029SCM) |
Applicant |
Hong Kong Etech Groups Limited |
Rm 747,7/F Star Hse 3 Salisbury Rd Tst |
Hong Kong,
CN
999077
|
|
Applicant Contact |
Haixin Chen |
Correspondent |
Feiying Drug & Medical Consulting Technical Service Group |
Rm 2401 Zhenye International Business Center, No. 3101-90 |
Qianhai Road |
Shenzhen,
CN
518052
|
|
Correspondent Contact |
Riley Chen |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/01/2024 |
Decision Date | 03/25/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|