The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Invacare® Solara® 3g And Solara® 3g Spree Manual Wheelchairs.
Device ID | K181090 |
510k Number | K181090 |
Device Name: | Invacare® Solara® 3G And Solara® 3G Spree Manual Wheelchairs |
Classification | Wheelchair, Mechanical |
Applicant | Invacare Corporation One Invacare Way Elyria, OH 44035 |
Contact | Elijah N. Wreh |
Correspondent | Elijah N. Wreh Invacare Corporation One Invacare Way Elyria, OH 44035 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-04-25 |
Decision Date | 2018-11-14 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INVACARE 78172572 2840082 Live/Registered |
Invacare Corporation 2002-10-09 |
INVACARE 73315171 1243496 Live/Registered |
Invacare Corporation 1981-06-17 |