The following data is part of a premarket notification filed by Jiangsu Intco Medical Equipment & Supply Co., Ltd. with the FDA for Ez-light 4000 Series Manual Wheelchair.
| Device ID | K002669 |
| 510k Number | K002669 |
| Device Name: | EZ-LIGHT 4000 SERIES MANUAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | JIANGSU INTCO MEDICAL EQUIPMENT & SUPPLY CO., LTD. 12390 EAST END AVE. Chino, CA 91710 |
| Contact | James Chu |
| Correspondent | James Chu JIANGSU INTCO MEDICAL EQUIPMENT & SUPPLY CO., LTD. 12390 EAST END AVE. Chino, CA 91710 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-28 |
| Decision Date | 2000-10-11 |