| Device Classification Name |
stimulator, muscle, powered
|
|---|
| 510(K) Number |
K113010 |
|---|
| Model |
FDES100(ED400), FDES101(ED401), FDES102(ED402). FDES103(ED403)
|
| Device Name |
FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR |
|---|
| Applicant |
| FAMIDOC TECHNOLOGY CO., LTD |
| east 2/f,zhixiang building,71 |
| block baoan district |
|
shenzhen,
|
|
| Contact |
cao liang |
| Regulation Number | 890.5850
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 10/11/2011 |
|---|
| Decision Date | 12/21/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Physical Medicine
|
|---|
| Review Advisory Committee |
Physical Medicine
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
