The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Model Action At Ii Manual Wheelchair.
Device ID | K984447 |
510k Number | K984447 |
Device Name: | MODEL ACTION AT II MANUAL WHEELCHAIR |
Classification | Wheelchair, Mechanical |
Applicant | INVACARE CORP. 1200 TAYLOR ST. Elyria, OH 44036 |
Contact | Edward A Kroll |
Correspondent | Edward A Kroll INVACARE CORP. 1200 TAYLOR ST. 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 | 1998-12-14 |
Decision Date | 1999-01-08 |
Summary: | summary |