The following data is part of a premarket notification filed by Danyang Jumao Healthcare Equipment Co.,ltd. with the FDA for Jumao Manual Wheelchair.
| Device ID | K082784 |
| 510k Number | K082784 |
| Device Name: | JUMAO MANUAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. NO.89 SHUANGFENG ROAD, JIEPAI TOWN Danyang; Jiangsu, CN 212323 |
| Contact | Qing Wang |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-09-23 |
| Decision Date | 2008-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822384002063 | K082784 | 000 |
| 00616784023816 | K082784 | 000 |
| M3683F0123301 | K082784 | 000 |
| M3683F0123201 | K082784 | 000 |
| M3683F0122301 | K082784 | 000 |
| M3683F0122201 | K082784 | 000 |
| M3683F0121301 | K082784 | 000 |
| M3683F0121201 | K082784 | 000 |
| 00822383003009 | K082784 | 000 |
| 00822383001708 | K082784 | 000 |
| 00822383003214 | K082784 | 000 |
| 00616784023915 | K082784 | 000 |
| 00616784024011 | K082784 | 000 |
| 00616784024110 | K082784 | 000 |
| 00822384002056 | K082784 | 000 |
| 00612479244221 | K082784 | 000 |
| 00612479244214 | K082784 | 000 |
| 00612479244207 | K082784 | 000 |
| 00612479244191 | K082784 | 000 |
| 00822383161266 | K082784 | 000 |
| 00822383259109 | K082784 | 000 |
| 00822383259093 | K082784 | 000 |
| 00822383003016 | K082784 | 000 |
| 00822383002996 | K082784 | 000 |
| 00822383003207 | K082784 | 000 |