The following data is part of a premarket notification filed by Heartway Medical Products Co., Ltd. with the FDA for Auto Folding Scooter, S21f.
| Device ID | K220227 |
| 510k Number | K220227 |
| Device Name: | Auto Folding Scooter, S21F |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | Heartway Medical Products Co., Ltd. No.18, Jingke Central 1st Rd., Nantun Dist Taichung City, TW 40852 |
| Contact | Ke-Min Jen |
| Correspondent | Ke-Min Jen Roc Chinese-European Industrial Research Society No. 58, Fu Chiun Street Hsin Chu City, TW 30067 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-27 |
| Decision Date | 2022-10-12 |