HOT/COLD PACK HOLDERS— 510(k) K823814

Name: FDA 510(k) clearance K823814
Creator: U.S. Food and Drug Administration
Published: 1983-01-14

Substantially Equivalent

Danek Medical, Inc.

FDA 510(k) clearance K823814 for HOT/COLD PACK HOLDERS, Substantially Equivalent on 1983-01-14. Applicant: Danek Medical, Inc.. Device class: 1.

Clearance details

Applicant: Danek Medical, Inc.
Product code: Code IME
Device class: Class 1
Regulation: 21 CFR 890.5700
Advisory panel: Physical Medicine
Date received: 1982-12-17
Decision date: 1983-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IME

view all

K923627 — COLD PACK1993-04-14
K915876 — HOTPAD1993-02-12
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

More clearances from Danek Medical, Inc.

view all

K994122 — BONE GRAFT WASHER, MODEL 9090114 - 90901182000-02-18
K993810 — CD HORIZON SPINAL SYSTEM2000-02-03
K993855 — ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM1999-12-15
K991528 — MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR1999-05-28
K990603 — MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM1999-03-10

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.