The following data is part of a premarket notification filed by Imc-heartway, Llc with the FDA for Pf-2 Battery Operated Electric Four Wheel Power Scooter.
| Device ID | K031897 |
| 510k Number | K031897 |
| Device Name: | PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER |
| Classification | Vehicle, Motorized 3-wheeled |
| 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 | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-19 |
| Decision Date | 2003-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871230343 | K031897 | 000 |