The following data is part of a premarket notification filed by Kunshan Aoshida Electric Technology Co., Ltd with the FDA for A08 Power Wheelchair.
| Device ID | K163204 |
| 510k Number | K163204 |
| Device Name: | A08 Power Wheelchair |
| Classification | Wheelchair, Powered |
| Applicant | Kunshan Aoshida Electric Technology Co., Ltd No. 65, Matang Road Kunshan, CN 215300 |
| Contact | Shen Wenhua |
| Correspondent | Junnata Chang IRC China 16F-2(16A), No. 462, Sec. 2, ChongDe Rd., Beitun Dist. Taichung, TW 406 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-15 |
| Decision Date | 2017-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971086400166 | K163204 | 000 |
| 06971086400012 | K163204 | 000 |
| 06971086400029 | K163204 | 000 |
| 06971086400036 | K163204 | 000 |
| 06971086400043 | K163204 | 000 |
| 06971086400050 | K163204 | 000 |
| 06971086400067 | K163204 | 000 |
| 06971086400074 | K163204 | 000 |
| 06971086400081 | K163204 | 000 |
| 06971086400098 | K163204 | 000 |
| 06971086400104 | K163204 | 000 |
| 06971086400111 | K163204 | 000 |
| 06971086400135 | K163204 | 000 |
| 06971086400142 | K163204 | 000 |
| 06971086400159 | K163204 | 000 |
| 06971086400180 | K163204 | 000 |