The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Resubmitted Ergometer Exercise Bike Model Ft1300.
| Device ID | K880865 |
| 510k Number | K880865 |
| Device Name: | RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300 |
| Classification | Exerciser, Powered |
| Applicant | INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Contact | James R Thaler |
| Correspondent | James R Thaler INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-01 |
| Decision Date | 1988-05-02 |