The following data is part of a premarket notification filed by Zhenjiang Assure Medical Equipment Co., Ltd with the FDA for Zhenjiang Asure Mechanical Wheelchair.
| Device ID | K112816 |
| 510k Number | K112816 |
| Device Name: | ZHENJIANG ASURE MECHANICAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD NO. FU CHIUN STREET Hsin Chu City, TW 30067 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD NO. FU CHIUN STREET Hsin Chu City, TW 30067 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-28 |
| Decision Date | 2012-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815067080335 | K112816 | 000 |
| 00815067079957 | K112816 | 000 |
| 00815067079940 | K112816 | 000 |
| 00815067012589 | K112816 | 000 |
| 00815067012572 | K112816 | 000 |
| 00815067012817 | K112816 | 000 |
| 00815067012800 | K112816 | 000 |
| 00815067012794 | K112816 | 000 |
| 00815067012787 | K112816 | 000 |
| 00815067012770 | K112816 | 000 |
| 00815067079964 | K112816 | 000 |
| 00815067079971 | K112816 | 000 |
| 00815067078561 | K112816 | 000 |
| 00815067078530 | K112816 | 000 |
| 00815067078523 | K112816 | 000 |
| 00815067070800 | K112816 | 000 |
| 00815067070794 | K112816 | 000 |
| 00815067070770 | K112816 | 000 |
| 00815067070763 | K112816 | 000 |
| 00815067079995 | K112816 | 000 |
| 00815067079988 | K112816 | 000 |
| 00815067012763 | K112816 | 000 |