The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Mcc-miv One 2 One Software.
| Device ID | K010364 |
| 510k Number | K010364 |
| Device Name: | MCC-MIV ONE 2 ONE SOFTWARE |
| Classification | Wheelchair, Powered |
| Applicant | INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Contact | Rae Ann Farrow |
| Correspondent | Rae Ann Farrow INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-07 |
| Decision Date | 2001-03-22 |