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FDA 510(k)

Quell

K-Number: K152954 · 2016-01-05

ApplicantNeurometrix, Inc.
Decision Date2016-01-05
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Quell is a medical device manufactured by Neurometrix, Inc.. It received FDA 510(k) clearance on 2016-01-05 under approval number K152954. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quell?

Quell is a medical device that received FDA 510(k) clearance on 2016-01-05. It is manufactured by Neurometrix, Inc.. The 510(k) number is K152954.

When was Quell approved by the FDA?

Quell received FDA 510(k) clearance on 2016-01-05, under approval number K152954.

What company makes Quell?

Quell is manufactured by Neurometrix, Inc..

What is the FDA product code for Quell?

The FDA product code for Quell is NUH.

Other Devices by Neurometrix, Inc.

DEN210046Quell-FM

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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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