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FDA 510(k)

QUADRA BLOC TENS PLUS

K-Number: K102278 · 2011-10-20

ApplicantGradient Technologies, LLC
Decision Date2011-10-20
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

QUADRA BLOC TENS PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Gradient Technologies, LLC. It received FDA 510(k) clearance on 2011-10-20 under 510(k) number K102278. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUADRA BLOC TENS PLUS?

QUADRA BLOC TENS PLUS is a medical device that received FDA 510(k) clearance on 2011-10-20. The listed applicant is Gradient Technologies, LLC. The 510(k) number is K102278.

When did QUADRA BLOC TENS PLUS receive FDA 510(k) clearance?

QUADRA BLOC TENS PLUS received FDA 510(k) clearance on 2011-10-20, under 510(k) number K102278.

Who is the listed applicant for QUADRA BLOC TENS PLUS?

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

What is the FDA product code for QUADRA BLOC TENS PLUS?

The FDA product code for QUADRA BLOC TENS PLUS is GZJ.

Related Clinical Trials

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.

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Other records listing Gradient Technologies, LLC as applicant

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.

K062547QUADRA BLOC TENS, MODEL 101

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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.

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