510(k) Report

FDA applicant

21st Century Scientific, Inc.

North Hollywood, CA3 decisions1990–20200 recalls

FDA records 3 decisions for 21st Century Scientific, Inc. (North Hollywood, CA) from 1990 to 2020: 3 510(k) clearances. All are in product code ITI (Wheelchair, Powered). Its devices cite 1 predicate, 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 21st Century Scientific, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — 21st Century Scientific, Inc. 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?

  • ITIWheelchair, Powered3decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K193599BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER…21st Century Scientific, Inc. · 2020
  • K954044Sidekick Power Wheelchair21st Century Scientific, Inc. · 1995
  • K901210Bounder VA Power Wheelchair21st Century Scientific, Inc. · 1990

All 3 as 21st Century Scientific, Inc. →

Other applicant names beginning “21st”

FDA records each applicant name separately; these may or may not be the same firm.

21st Century Group 1