ICY COLD ICE CAP— 510(k) K830416

Name: FDA 510(k) clearance K830416
Creator: U.S. Food and Drug Administration
Published: 1983-03-10

Substantially Equivalent

Ladora Ent.

FDA 510(k) clearance K830416 for ICY COLD ICE CAP, Substantially Equivalent on 1983-03-10. Applicant: Ladora Ent.. Device class: 1.

Clearance details

Applicant: Ladora Ent.
Product code: Code IME
Device class: Class 1
Regulation: 21 CFR 890.5700
Advisory panel: Physical Medicine
Date received: 1983-02-08
Decision date: 1983-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IME

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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

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.