The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Tilt/recliner For Power Wheelchairs, Model 2g.
Device ID | K991119 |
510k Number | K991119 |
Device Name: | TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G |
Classification | Wheelchair, Powered |
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 | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-02 |
Decision Date | 1999-08-19 |
Summary: | summary |