The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Rolls 3000 Series Wheelchair (youthmobile).
| Device ID | K884931 |
| 510k Number | K884931 |
| Device Name: | ROLLS 3000 SERIES WHEELCHAIR (YOUTHMOBILE) |
| Classification | Wheelchair, Mechanical |
| 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 | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-28 |
| Decision Date | 1988-12-12 |