# K032879: Navigator I

- Pathway: 510(k) (Traditional)
- Applicant: Adaptive Healthcare Technologies, Inc.
- Decided: Nov 13, 2003 after 59 days
- Product code: INI (Vehicle, Motorized 3-Wheeled)
- Device class: 2
- Regulation: 21 CFR 890.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K926295 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880425: Sterling (Motorized Vehicle), A-Bec Mobility, Inc. (1988) Summary page 1.
- K924515: Electric Mobility Rascal, Electric Mobility Corp. (1994)
- K830345: Scooter, Vehicle Motorized, Amigo Sales, Inc. (1983) Summary page 1.
- K935410: Hoveround MPV, Hoveround Corp. (1994) Summary page 1.
- K854051: Modular Power Base, Everest & Jennings, Inc. (1985)
- K945936: JAZZY, Pride Health Care, Inc. (1996) Summary page 1.
- K971043: Golden Eagle, Golden Technologies, Inc. (1997) Summary page 1.
- K955240: Omegatrac by Teftec, Teftec Corp. (1996). Our reading of the summary gave K955210, FDA’s number for Sas Salmonella H F,G, Antiserum (Sa Scientific, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “TEFTEC Corp. OMEGATRAC”.

## Indications for use
To provide improved mobility, both indoors and outdoors, for persons who have adequate upper body strength suitable for manual steering, and who have a medical condition that impairs their ability to stand for periods of time or to walk.

Source page: https://510kreport.com/device/K032879
Methodology: https://510kreport.com/methodology