510(k) Report

FDA applicant

Medcare Manufacturing, Inc.

Hsin-Chu City, TW1 decision2006–20060 recalls

FDA records 1 decision for Medcare Manufacturing, Inc. (Hsin-Chu City, TW) in 2006: 1 510(k) clearance. All are in product code IOR (Wheelchair, Mechanical). 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 Medcare Manufacturing, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medcare Manufacturing, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medcare Manufacturing, 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?

  • IORWheelchair, Mechanical1decision

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?

  • K061694Medcare Mechanical Wheelchair, Models MC-281S & MC-200SMedcare Manufacturing, Inc. · 2006

The one decision as Medcare Manufacturing, Inc. →

Other applicant names beginning “Medcare”

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

Medcare Products 20Medcare Custom Packaging, Inc. 11Medcare Medical Group, Inc. 8Medcare Disp Products, Inc. 6Medcare Flaga 4Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi 1