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FDA 510(k)

AGAR 7K TENS INSTRUMENT

K-Number: K862454 · 1987-03-25

ApplicantSolcoor, Inc.
Decision Date1987-03-25
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AGAR 7K TENS INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Solcoor, Inc.. It received FDA 510(k) clearance on 1987-03-25 under 510(k) number K862454. 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 AGAR 7K TENS INSTRUMENT?

AGAR 7K TENS INSTRUMENT is a medical device that received FDA 510(k) clearance on 1987-03-25. The listed applicant is Solcoor, Inc.. The 510(k) number is K862454.

When did AGAR 7K TENS INSTRUMENT receive FDA 510(k) clearance?

AGAR 7K TENS INSTRUMENT received FDA 510(k) clearance on 1987-03-25, under 510(k) number K862454.

Who is the listed applicant for AGAR 7K TENS INSTRUMENT?

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

What is the FDA product code for AGAR 7K TENS INSTRUMENT?

The FDA product code for AGAR 7K TENS INSTRUMENT is GZJ.

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Other records listing Solcoor, 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.

K882386AGAR 3K NEUROMUSCULAR STIMULATORK882387AGAR 4000 NEUROMUSCULAR STIMULATORK861895UNI-TENSK861894AGAR 9K TENSK861896UNI-TENS XL TENSK851265PEAK FLOWMETERS FOR SPIROMETRY

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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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