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FDA 510(k)

ELECTRO

K-Number: K041219 · 2004-08-04

ApplicantPermobil AB
Decision Date2004-08-04
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELECTRO is the device name listed in this FDA 510(k) record. The listed applicant is Permobil AB. It received FDA 510(k) clearance on 2004-08-04 under 510(k) number K041219. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRO?

ELECTRO is a medical device that received FDA 510(k) clearance on 2004-08-04. The listed applicant is Permobil AB. The 510(k) number is K041219.

When did ELECTRO receive FDA 510(k) clearance?

ELECTRO received FDA 510(k) clearance on 2004-08-04, under 510(k) number K041219.

Who is the listed applicant for ELECTRO?

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

What is the FDA product code for ELECTRO?

The FDA product code for ELECTRO is ITI.

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Related PubMed Literature

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PMID: 37861058Electroactive Polymers for On-Demand Drug Release.Advanced healthcare materials ()PMID: 31472187A translational framework for peripheral nerve stimulating electrodes: Reviewing the journey from concept to clinic.Journal of neuroscience methods ()PMID: 30614316A review of the FDA's 510(k) approvals process for electromagnetic devices used in body contouring.The Journal of dermatological treatment ()PMID: 30596410Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses. Final order.Federal register ()

Other records listing Permobil AB 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.

K190682Explorer MiniK191874F5 Corpus VSK123290M300 & M400K103477PERMOBIL M300 / M400K081964K450 POWERED WHEELCHAIRK071650C350 POWERED WHEELCHAIR

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Related Devices (Code: ITI)

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.

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.

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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