Utah Artifical Arm

FDA 510(k) K802642 · Motion Control, Inc.

Substantially Equivalent

510(k) numberK802642

Submission

Device name
Utah Artifical Arm
Applicant
Motion Control, Inc.
Mchenry, IL, US
Received
October 24, 1980
Decision date
November 12, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IRE – Joint, Elbow, External Limb Component, Powered
Device class
Class I (low risk)
Regulation
21 CFR 890.3420
Specialty
Physical Medicine

Other 510(k)s with product code IRE

510(k)DeviceApplicantDecision
K822632Elbow ProsthesisIRE · Traditional Hosmer Dorrance Corp.09/14/1982SE

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K862236Myolab II, Model ML-200IKN · Traditional 08/07/1986SE
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Questions and answers

When was Utah Artifical Arm cleared by the FDA?

Utah Artifical Arm (K802642) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 19 days after the submission was received.

What is the product code of K802642?

The FDA product code is IRE – Joint, Elbow, External Limb Component, Powered, a Class I (low risk) device regulated under 21 CFR 890.3420.