The following data is part of a premarket notification filed by Heartway Medical Products Co., Ltd. with the FDA for Heartway Power Mobility Scooter.
| Device ID | K132855 |
| 510k Number | K132855 |
| Device Name: | HEARTWAY POWER MOBILITY SCOOTER |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | HEARTWAY MEDICAL PRODUCTS CO., LTD. NO. 6 ROAD 25 TAICHUNG INDUSTRIAL PARK Taichung City, Taiwan, TW R.o.c. 408 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min HEARTWAY MEDICAL PRODUCTS CO., LTD. NO. 6 ROAD 25 TAICHUNG INDUSTRIAL PARK Taichung City, Taiwan, TW R.o.c. 408 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-12 |
| Decision Date | 2014-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871230398 | K132855 | 000 |