The following data is part of a premarket notification filed by Home Health Technology Co., Ltd. with the FDA for Home Health Power Wheelchair, Model Hc-200tr.
| Device ID | K043376 |
| 510k Number | K043376 |
| Device Name: | HOME HEALTH POWER WHEELCHAIR, MODEL HC-200TR |
| Classification | Wheelchair, Powered |
| Applicant | HOME HEALTH TECHNOLOGY CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen HOME HEALTH TECHNOLOGY CO., LTD. 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 | 2004-12-08 |
| Decision Date | 2005-01-10 |
| Summary: | summary |