The following data is part of a premarket notification filed by Guangdong Kaiyang Medical Technology Co., Ltd. with the FDA for Kaiyang Aluminum Wheelchair.
| Device ID | K101998 |
| 510k Number | K101998 |
| Device Name: | KAIYANG ALUMINUM WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | GUANGDONG KAIYANG MEDICAL TECHNOLOGY CO., LTD. YANFENG INDUSTRIAL AREA, DALI, NANHAI DISTRICT Foshan, CN 528231 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen GUANGDONG KAIYANG MEDICAL TECHNOLOGY CO., LTD. YANFENG INDUSTRIAL AREA, DALI, NANHAI DISTRICT Foshan, CN 528231 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-15 |
| Decision Date | 2010-10-04 |
| Summary: | summary |