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FDA 510(k)

VitalStim(R) Plus Electrotherapy System

K-Number: K153224 · 2016-02-17

ApplicantDjo, LLC
Decision Date2016-02-17
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

VitalStim(R) Plus Electrotherapy System is the device name listed in this FDA 510(k) record. The listed applicant is Djo, LLC. It received FDA 510(k) clearance on 2016-02-17 under 510(k) number K153224. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitalStim(R) Plus Electrotherapy System?

VitalStim(R) Plus Electrotherapy System is a medical device that received FDA 510(k) clearance on 2016-02-17. The listed applicant is Djo, LLC. The 510(k) number is K153224.

When did VitalStim(R) Plus Electrotherapy System receive FDA 510(k) clearance?

VitalStim(R) Plus Electrotherapy System received FDA 510(k) clearance on 2016-02-17, under 510(k) number K153224.

Who is the listed applicant for VitalStim(R) Plus Electrotherapy System?

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

What is the FDA product code for VitalStim(R) Plus Electrotherapy System?

The FDA product code for VitalStim(R) Plus Electrotherapy System is IPF.

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Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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