EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR
FDA 510(k) clearance K002670 · decided 2000-10-11
Clearance details
- K-number
- K002670
- Device name
- EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR
- Applicant
- Jiangsu Intco Medical Equipment & Supply Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-28
- Decision date
- 2000-10-11
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Chino, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Manual Mechanical Wheelchair, 18'' seat, , maximum patient weight: 250 lbs.; Marketed by M recall (Z-0642-05) | Cypress Medical Products, Ltd. | 2005-03-22 |
| Manual Mechanical Wheelchair, 16'' seat, , maximum patient weight: 250 lbs.; Marketed by M recall (Z-0643-05) | Cypress Medical Products, Ltd. | 2005-03-22 |
| Manual Mechanical Wheelchair, 24'' seat, , maximum patient weight: 450 lbs.; Marketed by M recall (Z-0644-05) | Cypress Medical Products, Ltd. | 2005-03-22 |
| Manual Mechanical Wheelchair, 20'' seat, , maximum patient weight: 350 lbs.; Marketed by M recall (Z-0645-05) | Cypress Medical Products, Ltd. | 2005-03-22 |
| Manual Mechanical Wheelchair, 22'' seat, , maximum patient weight: 350 lbs.; Marketed by M recall (Z-0646-05) | Cypress Medical Products, Ltd. | 2005-03-22 |