Medi-Stim

FDA 510(k) K921491 · Mid-Canada Medical

Substantially Equivalent

510(k) numberK921491

Submission

Device name
Medi-Stim
Applicant
Mid-Canada Medical
Mississauga, Ontario, CA
Received
March 30, 1992
Decision date
September 3, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LIH – Interferential Current Therapy
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

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K122944Gemore True Sine Interferential StimulatorLIH · Special Gemore Technology Co, Ltd.12/21/2012SE
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K100246MAX-IF1000LIH · Traditional Bio Protech, Inc.11/24/2010SE
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K092763If True Sine Interferential Stimulator, WL-2206DLIH · Special Well-Life Healthcare Limited10/08/2009SE
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More from Well-Life Healthcare Limited

510(k)DeviceDecision
K933237Medi-Stim, ModificationGZJ · Traditional 09/08/1994SE
K922839Mid-Canada MedicalIMI · Traditional 07/02/1993SE
K883309Multi-Care ChairINM · Traditional 09/30/1988SE
K883308Parker Bathing SystemILJ · Traditional 09/22/1988SE

Questions and answers

When was Medi-Stim cleared by the FDA?

Medi-Stim (K921491) received a 510(k) decision of Substantially Equivalent on September 3, 1992, 157 days after the submission was received.

What is the product code of K921491?

The FDA product code is LIH – Interferential Current Therapy, a Class II (moderate risk) device regulated under 21 CFR 882.5890.