The following data is part of a premarket notification filed by Genemax Medical Products Industry Corp. with the FDA for Genemax Power Wheelchair, Pw3.
| Device ID | K042748 |
| 510k Number | K042748 |
| Device Name: | GENEMAX POWER WHEELCHAIR, PW3 |
| Classification | Wheelchair, Powered |
| Applicant | GENEMAX MEDICAL PRODUCTS INDUSTRY CORP. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen GENEMAX MEDICAL PRODUCTS INDUSTRY CORP. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-04 |
| Decision Date | 2004-11-12 |
| Summary: | summary |