DR KOOL— 510(k) K935841

Name: FDA 510(k) clearance K935841
Creator: U.S. Food and Drug Administration
Published: 1994-08-29

Substantially Equivalent for Some Indications

Toronto Medical Corp.

FDA 510(k) clearance K935841 for DR KOOL, Substantially Equivalent for Some Indications on 1994-08-29. Applicant: Toronto Medical Corp.. Device class: 2.

Clearance details

Applicant: Toronto Medical Corp.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1993-12-07
Decision date: 1994-08-29
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Canada L1w2y5, CA

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

More clearances from Toronto Medical Corp.

view all

K950682 — W2 WRIST CPM UNIT1995-09-13
K935587 — MULTILINK SHOULDER CPM UNIT1994-12-14
K925926 — MOBILIMB T1 TOE CPM UNIT1993-03-22
K900466 — MOBILIMB W1 WRIST CPM UNIT1990-03-12
K900795 — MOBILIMB L4 LOWER LIMB CPM UNIT1990-03-12

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