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FDA 510(k)

Q-TENS

K-Number: K912460 · 1991-11-13

ApplicantQuantitative Medicine, Inc.
Decision Date1991-11-13
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Q-TENS is the device name listed in this FDA 510(k) record. The listed applicant is Quantitative Medicine, Inc.. It received FDA 510(k) clearance on 1991-11-13 under 510(k) number K912460. 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 Q-TENS?

Q-TENS is a medical device that received FDA 510(k) clearance on 1991-11-13. The listed applicant is Quantitative Medicine, Inc.. The 510(k) number is K912460.

When did Q-TENS receive FDA 510(k) clearance?

Q-TENS received FDA 510(k) clearance on 1991-11-13, under 510(k) number K912460.

Who is the listed applicant for Q-TENS?

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

What is the FDA product code for Q-TENS?

The FDA product code for Q-TENS is GZJ.

Other records listing Quantitative Medicine, Inc. 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.

K963608QUANTITATIVE SENTINEL SYSTEMK960109QUANTITATIVE SENTINEL SYSTEMK923255Q-SDK912462Q-MS NEUROMUSCULAR STIMULATORK912463MICRO-QK904603QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM

View all 8 devices →

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

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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