COLD PACK— 510(k) K923627

Name: FDA 510(k) clearance K923627
Creator: U.S. Food and Drug Administration
Published: 1993-04-14

Substantially Equivalent

Friendmed Products

FDA 510(k) clearance K923627 for COLD PACK, Substantially Equivalent on 1993-04-14. Applicant: Friendmed Products. Device class: 1.

Clearance details

Applicant: Friendmed Products
Product code: Code IME
Device class: Class 1
Regulation: 21 CFR 890.5700
Advisory panel: Physical Medicine
Date received: 1992-07-21
Decision date: 1993-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IME

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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
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.