The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Invacare Youthmobile 5000 Series Wheelchair.
Device ID | K884932 |
510k Number | K884932 |
Device Name: | INVACARE YOUTHMOBILE 5000 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 | 1988-11-28 |
Decision Date | 1988-12-12 |