The following data is part of a premarket notification filed by Jiangsu Intco Medical Equipment & Supply Co., Ltd. with the FDA for Ez-comfort Transporter 2000 Series.
Device ID | K002673 |
510k Number | K002673 |
Device Name: | EZ-COMFORT TRANSPORTER 2000 SERIES |
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 |