The following data is part of a premarket notification filed by Pihsiang Machinery Mfg. Co. Ltd. with the FDA for Phfw-10.
| Device ID | K022539 |
| 510k Number | K022539 |
| Device Name: | PHFW-10 |
| Classification | Wheelchair, Powered |
| Applicant | PIHSIANG MACHINERY MFG. CO. LTD. 1101 ILLINOIS P.O. BOX 187 Neodesha, KS 66757 |
| Contact | Chris Tinsley |
| Correspondent | Chris Tinsley PIHSIANG MACHINERY MFG. CO. LTD. 1101 ILLINOIS P.O. BOX 187 Neodesha, KS 66757 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-01 |
| Decision Date | 2002-11-19 |