The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Invacare Power 9000 Series Wheelchair.
Device ID | K900565 |
510k Number | K900565 |
Device Name: | INVACARE POWER 9000 SERIES WHEELCHAIR |
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 | 1990-02-07 |
Decision Date | 1990-02-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841447101505 | K900565 | 000 |
00841447101475 | K900565 | 000 |
00841447101055 | K900565 | 000 |
00841447100843 | K900565 | 000 |