The following data is part of a premarket notification filed by Robert Hoening Mobility Systems, Inc. with the FDA for Duet Bicycle/wheelchair.
| Device ID | K913759 |
| 510k Number | K913759 |
| Device Name: | DUET BICYCLE/WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | ROBERT HOENING MOBILITY SYSTEMS, INC. C/O ARENT/FOX/KINT/PLOTK/KAHN 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Contact | R Pendergast |
| Correspondent | R Pendergast ROBERT HOENING MOBILITY SYSTEMS, INC. C/O ARENT/FOX/KINT/PLOTK/KAHN 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-22 |
| Decision Date | 1991-10-24 |