The following data is part of a premarket notification filed by Nvacare Corp. with the FDA for Action At Manual Wheelchair.
Device ID | K941989 |
510k Number | K941989 |
Device Name: | ACTION AT MANUAL WHEELCHAIR |
Classification | Wheelchair, Mechanical |
Applicant | NVACARE CORP. 899 CLEVLAND ST. P.O. BOX 4028 Elyria, OH 44036 -2125 |
Contact | Edward A Kroll |
Correspondent | Edward A Kroll NVACARE CORP. 899 CLEVLAND ST. P.O. BOX 4028 Elyria, OH 44036 -2125 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-25 |
Decision Date | 1994-05-11 |