The following data is part of a premarket notification filed by Ivacare Corp. with the FDA for Arrow Xt Powered Wheelchair.
| Device ID | K865072 |
| 510k Number | K865072 |
| Device Name: | ARROW XT POWERED WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | IVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Contact | James R Thaler |
| Correspondent | James R Thaler IVACARE 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 | 1986-12-29 |
| Decision Date | 1987-01-21 |