The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Arrow Micro Computer Control Switch & Environ. Sys.
Device ID | K885261 |
510k Number | K885261 |
Device Name: | ARROW MICRO COMPUTER CONTROL SWITCH & ENVIRON. SYS |
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 | 1988-12-22 |
Decision Date | 1989-03-15 |