The following data is part of a premarket notification filed by Imc-heartway, Llc with the FDA for Hp-3 Hd Electric Wheelchair.
| Device ID | K030427 |
| 510k Number | K030427 |
| Device Name: | HP-3 HD ELECTRIC WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | IMC-HEARTWAY, LLC 6140 MID METRO DRIVE, SUITE 6 Fort Myers, FL 33912 |
| Contact | Juan Carlos Rivera |
| Correspondent | Juan Carlos Rivera IMC-HEARTWAY, LLC 6140 MID METRO DRIVE, SUITE 6 Fort Myers, FL 33912 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-10 |
| Decision Date | 2003-04-18 |
| Summary: | summary |