| Device Classification Name |
Wheelchair, Standup
|
| 510(k) Number |
K863118 |
| Device Name |
I.D.C. STANDUP WHEELCHAIRS |
| Applicant |
| Intl. Diffusion Consommateur |
| C/O Norex U.S.A. Inc. |
| 1032 31st St., NW |
|
Washington,
DC
20007
|
|
| Applicant Contact |
DARIENNE MOYER |
| Correspondent |
| Intl. Diffusion Consommateur |
| C/O Norex U.S.A. Inc. |
| 1032 31st St., NW |
|
Washington,
DC
20007
|
|
| Correspondent Contact |
DARIENNE MOYER |
| Regulation Number | 890.3900 |
| Classification Product Code |
|
| Date Received | 08/14/1986 |
| Decision Date | 08/21/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|