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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 a medical device manufactured by Djo, LLC. It received FDA 510(k) clearance on 2016-02-17 under approval 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. It is manufactured by Djo, LLC. The 510(k) number is K153224.

When was VitalStim(R) Plus Electrotherapy System approved by the FDA?

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

What company makes VitalStim(R) Plus Electrotherapy System?

VitalStim(R) Plus Electrotherapy System is manufactured by Djo, LLC.

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)

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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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