ISOCOMFORTER— 510(k) K936143

Name: FDA 510(k) clearance K936143
Creator: U.S. Food and Drug Administration
Published: 1994-07-12

Substantially Equivalent for Some Indications

Isocomforter, Inc.

FDA 510(k) clearance K936143 for ISOCOMFORTER, Substantially Equivalent for Some Indications on 1994-07-12. Applicant: Isocomforter, Inc.. Device class: 2.

Clearance details

Applicant: Isocomforter, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1993-12-27
Decision date: 1994-07-12
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Kentwood, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ILO

view all

K213097 — Armory Motion2022-06-10
K083008 — COOLSKIN2009-06-10
K073675 — T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP2008-05-08
K072152 — JUNIPER CLN1 DERMAL COOLING DEVICE2007-09-07
K070402 — MODIFICATION TO POLAR CARE 5002007-03-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.