The following data is part of a premarket notification filed by Transworld Mobility Distribution, L.l.c. with the FDA for Hp-5, Battery Operated, Rear Wheel Drive, Power Wheelchair.
| Device ID | K011744 |
| 510k Number | K011744 |
| Device Name: | HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | TRANSWORLD MOBILITY DISTRIBUTION, L.L.C. 6140 MILD METRO DR. SUITE #6 Fort Myers, FL 33912 |
| Contact | Juan C Rivera |
| Correspondent | Juan C Rivera TRANSWORLD MOBILITY DISTRIBUTION, L.L.C. 6140 MILD METRO DR. SUITE #6 Fort Myers, FL 33912 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-05 |
| Decision Date | 2001-08-24 |