The following data is part of a premarket notification filed by Heartway Medical Products Co., Ltd. with the FDA for Heartway Power Mobility Scooter, S12.
| Device ID | K092650 |
| 510k Number | K092650 |
| Device Name: | HEARTWAY POWER MOBILITY SCOOTER, S12 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | HEARTWAY MEDICAL PRODUCTS CO., LTD. ROC CHINESE- EUROPEAN IND. NO.58, FU-CHUIN STREET Hsin Chu City,,, Tw Hsq, TW 30067 |
| Contact | Ke Min Jen |
| Correspondent | Ke Min Jen HEARTWAY MEDICAL PRODUCTS CO., LTD. ROC CHINESE- EUROPEAN IND. NO.58, FU-CHUIN STREET Hsin Chu City,,, Tw Hsq, 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 | 2009-08-27 |
| Decision Date | 2009-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871230381 | K092650 | 000 |