The following data is part of a premarket notification filed by Aikin Healthcare Co., Ltd with the FDA for Mechanical Wheelchair.
| Device ID | K120032 |
| 510k Number | K120032 |
| Device Name: | MECHANICAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | AIKIN HEALTHCARE CO., LTD 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls AIKIN HEALTHCARE CO., LTD 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-04 |
| Decision Date | 2012-04-13 |