The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Micro Computer Controls, Model# Mcc-mk-rii-x.
| Device ID | K914938 |
| 510k Number | K914938 |
| Device Name: | MICRO COMPUTER CONTROLS, MODEL# MCC-MK-RII-X |
| Classification | Wheelchair, Powered |
| Applicant | INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll 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 | 1991-11-04 |
| Decision Date | 1992-01-13 |