The following data is part of a premarket notification filed by Heartway Medical Products Co., Ltd. with the FDA for Heartway Power Mobility Scooter, S8.
| Device ID | K092155 |
| 510k Number | K092155 |
| Device Name: | HEARTWAY POWER MOBILITY SCOOTER, S8 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | HEARTWAY MEDICAL PRODUCTS CO., LTD. NO.58, FU-CHIUN ST. Hsin-chu City, TW 408 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen HEARTWAY MEDICAL PRODUCTS CO., LTD. NO.58, FU-CHIUN ST. Hsin-chu City, TW 408 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-16 |
| Decision Date | 2009-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871230442 | K092155 | 000 |