The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Model Top End Terminator Ss Manual Wheelchair.
Device ID | K990157 |
510k Number | K990157 |
Device Name: | MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR |
Classification | Wheelchair, Mechanical |
Applicant | INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 |
Contact | Edward A Kroll |
Correspondent | Edward A Kroll INVACARE CORP. ONE INVACARE WAY 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 | 1999-01-19 |
Decision Date | 1999-02-03 |
Summary: | summary |