The following data is part of a premarket notification filed by Valentine Intl. Ltd. with the FDA for Valentine Steel Wheelchair.
| Device ID | K130017 |
| 510k Number | K130017 |
| Device Name: | VALENTINE STEEL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | VALENTINE INTL. LTD. 8TH FL., NO. 149, SEC. 2, TA TUNG RD. HSICHIH DISTRICT New Taipei City, TW 221 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min VALENTINE INTL. LTD. 8TH FL., NO. 149, SEC. 2, TA TUNG RD. HSICHIH DISTRICT New Taipei City, TW 221 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-02 |
| Decision Date | 2014-05-28 |
| Summary: | summary |