HOTPAD— 510(k) K915876

Substantially Equivalent

Ten Comfort Corp.

FDA 510(k) clearance K915876 for HOTPAD, Substantially Equivalent on 1993-02-12. Applicant: Ten Comfort Corp..

Clearance details

Applicant: Ten Comfort Corp.
Product code: Code IME
Advisory panel: Physical Medicine
Date received: 1991-12-19
Decision date: 1993-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taiwan R.O.C., CN

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Adverse events under product code IME

product code IME

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.