The following data is part of a premarket notification filed by Marken International, Inc. with the FDA for Accommodator Wheelchair, Model #2000x.
| Device ID | K021145 |
| 510k Number | K021145 |
| Device Name: | ACCOMMODATOR WHEELCHAIR, MODEL #2000X |
| Classification | Wheelchair, Mechanical |
| Applicant | MARKEN INTERNATIONAL, INC. 851 BRIDGER STR. SUITE 1 Bozeman, MT 59715 |
| Contact | Steve Riffel |
| Correspondent | Steve Riffel MARKEN INTERNATIONAL, INC. 851 BRIDGER STR. SUITE 1 Bozeman, MT 59715 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-09 |
| Decision Date | 2002-05-16 |