The following data is part of a premarket notification filed by Invacare Corporation with the FDA for A-series Integral Controller, Model Int/dl40i.
Device ID | K073134 |
510k Number | K073134 |
Device Name: | A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I |
Classification | Wheelchair, Powered |
Applicant | INVACARE CORPORATION ONE INVACARE WAY Elyria, OH 44035 |
Contact | Carroll Martin |
Correspondent | Carroll Martin INVACARE CORPORATION ONE INVACARE WAY Elyria, OH 44035 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-07 |
Decision Date | 2007-11-16 |
Summary: | summary |