Actitrainer

FDA 510(k) K080545 · Actigraph, LLC

Substantially Equivalent

510(k) numberK080545

Submission

Device name
Actitrainer
Applicant
Actigraph, LLC
Pensacola, FL, US
Received
February 27, 2008
Decision date
July 24, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ISD – Exerciser, Measuring
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5360
Specialty
Physical Medicine

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K143512ActiSpec Activity MonitorISD · Traditional Sleep Modus, Inc.08/26/2015SE
K112121Ergoselect/GeISD · Traditional Ergoline GmbH10/31/2012SE
K053078Ergoselect 100 K/P, Ergoselect 200 K/PISD · Traditional Ergoline GmbH04/27/2006SE
K990866Quinton Medtrack CR Plus TreadmillISD · Traditional Quinton, Inc.04/29/1999SE
K990813RehcorISD · Traditional Electromed Corp.04/12/1999SE
K962855ULE-2, MULE-2, Hand Accessory KitISD · Traditional Penny and Giles Biometrics , Ltd.12/11/1996SE
K952163David Back Clinic SystemISD · Traditional Kinetic Resources, Inc.08/12/1996SE
K941033Physio HabISD · Traditional Longo Industries02/27/1995SE

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Questions and answers

When was Actitrainer cleared by the FDA?

Actitrainer (K080545) received a 510(k) decision of Substantially Equivalent on July 24, 2008, 148 days after the submission was received.

What is the product code of K080545?

The FDA product code is ISD – Exerciser, Measuring, a Class II (moderate risk) device regulated under 21 CFR 890.5360.