KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS
FDA 510(k) clearance K982336 · decided 1998-08-21
Clearance details
- K-number
- K982336
- Device name
- KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS
- Applicant
- Invacare Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-06
- Decision date
- 1998-08-21
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Elyria, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Kuschall K Junior Manual wheelchair recall (Z-0421-2010) | Invacare Corporation | 2009-11-25 |
| Kuschall''s K3/K4 Series of Manual Wheelchair, Model Airlite. recall (Z-1486-06) | Invacare Corporation | 2006-09-06 |