The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Ride-lite 9000 Series Wheelchair.
Device ID | K881951 |
510k Number | K881951 |
Device Name: | RIDE-LITE 9000 SERIES WHEELCHAIR |
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 | 1988-05-10 |
Decision Date | 1988-05-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841447102830 | K881951 | 000 |
00841447102823 | K881951 | 000 |
00841447102809 | K881951 | 000 |
00841447113089 | K881951 | 000 |