The following data is part of a premarket notification filed by Transworld Mobility Distribution, L.l.c. with the FDA for Pf-3, Battery Operated, Four Wheel, Power Scooter, Model Pf-3.
| Device ID | K020001 |
| 510k Number | K020001 |
| Device Name: | PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | TRANSWORLD MOBILITY DISTRIBUTION, L.L.C. 6140 MID METRO DR. SUITE #6 Fort Myers, FL 33912 |
| Contact | Juan C Rivera |
| Correspondent | Juan C Rivera TRANSWORLD MOBILITY DISTRIBUTION, L.L.C. 6140 MID METRO DR. 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 | 2002-01-02 |
| Decision Date | 2002-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871230350 | K020001 | 000 |