The following data is part of a premarket notification filed by Heartway Medical Products Co., Ltd. with the FDA for Heartway Power Mobility Scooter, Brio S19.
| Device ID | K150987 |
| 510k Number | K150987 |
| Device Name: | HEARTWAY Power Mobility Scooter, BRIO S19 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | HEARTWAY Medical Products Co., Ltd. No.6 Road 25, Taichung Industrial Park, Taichung City, TW 40850 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min HEARTWAY Medical Products Co., Ltd. No.6 Road 25, Taichung Industrial Park, Taichung City, TW 40850 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-14 |
| Decision Date | 2015-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871230190 | K150987 | 000 |