RE-HEATER, HOT PACK— 510(k) K863654

Name: FDA 510(k) clearance K863654
Creator: U.S. Food and Drug Administration
Published: 1986-10-23

Substantially Equivalent

K & L Ent.

FDA 510(k) clearance K863654 for RE-HEATER, HOT PACK, Substantially Equivalent on 1986-10-23. Applicant: K & L Ent.. Device class: 1.

Clearance details

Applicant: K & L Ent.
Product code: Code IME
Device class: Class 1
Regulation: 21 CFR 890.5700
Advisory panel: Physical Medicine
Date received: 1986-09-18
Decision date: 1986-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gardena, CA, US

Download summary PDF View on FDA.gov ↗

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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.