| Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
| 510(k) Number |
K993823 |
| Device Name |
MED-4000 |
| Applicant |
| Micro Current Technology, Inc. |
| 4822 California Ave., SW, |
| Suite 201 |
|
Seattle,
WA
98116
|
|
| Applicant Contact |
JAMES Y SUZUKI |
| Correspondent |
| Underwriters Laboratories, Inc. |
| 2600 NW Lake Rd. |
|
Camas,
WA
98607
|
|
| Correspondent Contact |
ROBERT M BOONSTRA |
| Regulation Number | 882.5890 |
| Classification Product Code |
|
| Date Received | 11/12/1999 |
| Decision Date | 11/19/1999 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
Yes
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|