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FDA 510(k)

TENS GB1001 DEVICE

K-Number: K850855 · 1986-01-09

ApplicantMedicon, Inc.
Decision Date1986-01-09
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS GB1001 DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medicon, Inc.. It received FDA 510(k) clearance on 1986-01-09 under 510(k) number K850855. 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 TENS GB1001 DEVICE?

TENS GB1001 DEVICE is a medical device that received FDA 510(k) clearance on 1986-01-09. The listed applicant is Medicon, Inc.. The 510(k) number is K850855.

When did TENS GB1001 DEVICE receive FDA 510(k) clearance?

TENS GB1001 DEVICE received FDA 510(k) clearance on 1986-01-09, under 510(k) number K850855.

Who is the listed applicant for TENS GB1001 DEVICE?

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

What is the FDA product code for TENS GB1001 DEVICE?

The FDA product code for TENS GB1001 DEVICE is GZJ.

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Other records listing Medicon, 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.

K962087SERVOTRONIC EC100 SYSTEMK952168TITANIUM MANDIBULAR FRACTURE SYSTEMK850852INFRARAX DEVICEK844702GAUZE ASORBABLEK844573ABSORBABLE GAUZE PRODUCTSK844574WHEELCHAIRS

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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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