| Device Classification Name |
Stimulator, Muscle, Powered
|
| 510(k) Number |
K030254 |
| Device Name |
INTERFERENTIAL STIMULATOR, MODEL RTM1000 |
| Applicant |
| Ryan Telemedicine |
| 1011 Brioso Dr. |
|
Costa Mesa,
CA
92627
|
|
| Applicant Contact |
JIM KLETT |
| Correspondent |
| Underwriters Laboratories, Inc. |
| 2600 NW Lake Rd. |
|
Camas,
WA
98607
|
|
| Correspondent Contact |
JOHN SO |
| Regulation Number | 890.5850 |
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 01/24/2003 |
| Decision Date | 02/26/2003 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
Yes
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|