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FDA 510(k)

ACTITRAINER

K-Number: K080545 · 2008-07-24

ApplicantActigraph, LLC
Decision Date2008-07-24
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ACTITRAINER is the device name listed in this FDA 510(k) record. The listed applicant is Actigraph, LLC. It received FDA 510(k) clearance on 2008-07-24 under 510(k) number K080545. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTITRAINER?

ACTITRAINER is a medical device that received FDA 510(k) clearance on 2008-07-24. The listed applicant is Actigraph, LLC. The 510(k) number is K080545.

When did ACTITRAINER receive FDA 510(k) clearance?

ACTITRAINER received FDA 510(k) clearance on 2008-07-24, under 510(k) number K080545.

Who is the listed applicant for ACTITRAINER?

The FDA 510(k) record lists Actigraph, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTITRAINER?

The FDA product code for ACTITRAINER is ISD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Actigraph, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231532ActiGraph LEAP activity monitor (ActiGraph LEAP)

Related Devices (Code: ISD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202979MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal UltraLode B.V.K183296REAL Immersive SystemPenumbra, Inc.K112121ERGOSELECT/GEErgoline GmbHK053078ERGOSELECT 100 K/P, ERGOSELECT 200 K/PErgoline GmbHK990866QUINTON MEDTRACK CR PLUS TREADMILLQuinton, Inc.K990813REHCORElectromed Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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