510(k) Report

FDA applicant

Warepalmy Enterprise, LLC (Usa)

Phoenix, AZ7 decisions1998–20010 recalls

FDA records 7 decisions for Warepalmy Enterprise, LLC (Usa) (Phoenix, AZ) from 1998 to 2001: 7 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and ITI (Wheelchair, Powered). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Warepalmy Enterprise, LLC (Usa)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Warepalmy Enterprise, LLC (Usa) since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Warepalmy Enterprise, LLC (Usa) by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • INIVehicle, Motorized 3-Wheeled6decisions
  • ITIWheelchair, Powered1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K012791C.T.M. Mobility Scooter Model # HS-320Warepalmy Enterprise, LLC (Usa) · 20012cite it
  • K002983C.T.M. Power Chair, Model HS-5600Warepalmy Enterprise, LLC (Usa) · 20001cites it
  • K983662C.T.M. Mobility Scooter, Model # HS-686Warepalmy Enterprise, LLC (Usa) · 19981cites it

What has FDA decided for it lately?

  • K012792C.T.M. Mobitiy Scooter Model #HS-360Warepalmy Enterprise, LLC (Usa) · 2001
  • K012791C.T.M. Mobility Scooter Model # HS-320Warepalmy Enterprise, LLC (Usa) · 2001
  • K002983C.T.M. Power Chair, Model HS-5600Warepalmy Enterprise, LLC (Usa) · 2000
  • K000354C.T.M. Mobility Scooters HS-666, HS-730, HS-570Warepalmy Enterprise, LLC (Usa) · 2000
  • K000356C.T.M. Mobility Scooter, Model H2-686, HS-740, HS-580Warepalmy Enterprise, LLC (Usa) · 2000
  • K983663C.T.M. Mobility Scooter, Model # HS-666Warepalmy Enterprise, LLC (Usa) · 1998
  • K983662C.T.M. Mobility Scooter, Model # HS-686Warepalmy Enterprise, LLC (Usa) · 1998

All 7 as Warepalmy Enterprise, LLC (Usa) →