The following data is part of a premarket notification filed by Jiangsu Healthy Way Medical Equipment Co;ltd with the FDA for Jiangsu Healthy Way Mechanical Wheelchair.
| Device ID | K112948 |
| 510k Number | K112948 |
| Device Name: | JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | JIANGSU HEALTHY WAY MEDICAL EQUIPMENT CO;LTD INDUSTRIAL RESEARCH SOCIETY NO.58 FU CHUN ST. Hsin Chu City, TW 30067 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min JIANGSU HEALTHY WAY MEDICAL EQUIPMENT CO;LTD INDUSTRIAL RESEARCH SOCIETY NO.58 FU CHUN ST. 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 | 2011-10-04 |
| Decision Date | 2012-03-28 |
| Summary: | summary |