The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Storm Series, Power 9000 Series And Power Tiger With Gyroscope Control.
| Device ID | K993413 |
| 510k Number | K993413 |
| Device Name: | STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL |
| Classification | Wheelchair, Powered |
| Applicant | INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 |
| Contact | Edwaed A Kroll |
| Correspondent | Edwaed A Kroll INVACARE CORP. ONE INVACARE WAY 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 | 1999-10-12 |
| Decision Date | 1999-12-15 |
| Summary: | summary |