The following data is part of a premarket notification filed by Eurogreen International Inc. with the FDA for Supachair Powered Wheelchair: Combi 18, Combi 18sp, Combi 20, Combi 20sp.
| Device ID | K173313 |
| 510k Number | K173313 |
| Device Name: | SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP |
| Classification | Wheelchair, Powered |
| Applicant | Eurogreen International Inc. No. 48, Lane 220, Sec. 1, Fu-Zun Rd., Yuan-Lin Township Chang-hua County, CN 51055 |
| Contact | David Hsieh |
| Correspondent | David Hsieh Eurogreen International Inc. No. 48, Lane 220, Sec. 1, Fu-Zun Rd., Yuan-Lin Township Chang-hua County, CN 51055 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-19 |
| Decision Date | 2018-02-13 |
| Summary: | summary |