FDA applicant
Ten Comfort Corp.
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
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.
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.
See the 510(k) Report