The following data is part of a premarket notification filed by Heartway Medical Products Co., Ltd. with the FDA for Mechanical Folding Wheel Chair.
| Device ID | K973491 |
| 510k Number | K973491 |
| Device Name: | MECHANICAL FOLDING WHEEL CHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | HEARTWAY MEDICAL PRODUCTS CO., LTD. ROAD 5, NO. 4, TAICHUNG INDUSTRIAL PARK Taichung, TW |
| Contact | Kenny Ho |
| Correspondent | Kenny Ho HEARTWAY MEDICAL PRODUCTS CO., LTD. ROAD 5, NO. 4, TAICHUNG INDUSTRIAL PARK Taichung, TW |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-15 |
| Decision Date | 1997-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871230466 | K973491 | 000 |