HOTPAD— 510(k) K915876

Name: FDA 510(k) clearance K915876
Creator: U.S. Food and Drug Administration
Published: 1993-02-12

Substantially Equivalent

Ten Comfort Corp.

FDA 510(k) clearance K915876 for HOTPAD, Substantially Equivalent on 1993-02-12. Applicant: Ten Comfort Corp.. Device class: 1.

Clearance details

Applicant: Ten Comfort Corp.
Product code: Code IME
Device class: Class 1
Regulation: 21 CFR 890.5700
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

Download summary PDF View on FDA.gov ↗

Recent devices under product code IME

view all

K923627 — COLD PACK1993-04-14
K921446 — HOT OR COLD PACK (THERMIPAQ)1992-07-13
K905207 — MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS1991-01-22
K882413 — SUBOCCIPITAL ICE PILLOW1988-11-30
K863654 — RE-HEATER, HOT PACK1986-10-23

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.