The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Storm Tdx Power Wheelchair.
Device ID | K023589 |
510k Number | K023589 |
Device Name: | STORM TDX POWER WHEELCHAIR |
Classification | Wheelchair, Powered |
Applicant | INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 -2125 |
Contact | Rae Ann Farrow |
Correspondent | Rae Ann Farrow INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 -2125 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-25 |
Decision Date | 2002-11-19 |
Summary: | summary |