Quell

FDA 510(k) K152954 · Neurometrix, Inc.

Substantially Equivalent

510(k) numberK152954

Submission

Device name
Quell
Applicant
Neurometrix, Inc.
Waltham, MA, US
Received
October 7, 2015
Decision date
January 5, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

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K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)NUH · Traditional Shenzhen Jiantuo Electronics Co., Ltd.12/31/2025SE
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K243131Triathlon ProNUH · Traditional Sigma Biomedical11/07/2025SE

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Questions and answers

When was Quell cleared by the FDA?

Quell (K152954) received a 510(k) decision of Substantially Equivalent on January 5, 2016, 90 days after the submission was received.

What is the product code of K152954?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.