The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Model #1555 Remote Joystick.
Device ID | K880364 |
510k Number | K880364 |
Device Name: | MODEL #1555 REMOTE JOYSTICK |
Classification | Wheelchair, Powered |
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 | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-26 |
Decision Date | 1988-09-19 |