The following data is part of a premarket notification filed by Heartway Medical Products Co., Ltd. with the FDA for Heartway Power Mobility Scooter, S9.
Device ID | K092154 |
510k Number | K092154 |
Device Name: | HEARTWAY POWER MOBILITY SCOOTER, S9 |
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 |
---|---|---|
04719871230459 | K092154 | 000 |