The following data is part of a premarket notification filed by Imc-heartway, Llc with the FDA for Imc Heartway, Llc Electric Powered Wheelchair, Model Allure (hp6).
| Device ID | K063328 |
| 510k Number | K063328 |
| Device Name: | IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6) |
| Classification | Wheelchair, Powered |
| Applicant | IMC-HEARTWAY, LLC 13050 METRO PARKWAY BAY 5 Fort Myers, FL 33966 |
| Contact | Michael Chen |
| Correspondent | Michael Chen IMC-HEARTWAY, LLC 13050 METRO PARKWAY BAY 5 Fort Myers, FL 33966 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-03 |
| Decision Date | 2007-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871230015 | K063328 | 000 |