510(k) Report

FDA applicant

Ten Comfort Corp.

Taiwan R.O.C., CN1 decision1993–19930 recalls

FDA records 1 decision for Ten Comfort Corp. (Taiwan R.O.C., CN) in 1993: 1 510(k) clearance. All are in product code IME (Pack, Hot Or Cold, Reusable). 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 Ten Comfort Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ten Comfort Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ten Comfort Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ten Comfort Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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