FDA 510(k)

Quell

K-Number: K152954 · 2016-01-05

Decision Date2016-01-05

Product CodeNUH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Quell is the device name listed in this FDA 510(k) record. The listed applicant is Neurometrix, Inc.. It received FDA 510(k) clearance on 2016-01-05 under 510(k) 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. The listed applicant is Neurometrix, Inc.. The 510(k) number is K152954.

When did Quell receive FDA 510(k) clearance?

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

Who is the listed applicant for Quell?

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

What is the FDA product code for Quell?

The FDA product code for Quell is NUH.

Related Devices (Code: NUH)

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.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited K251958VEINOPLUS BackDynapulse Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.