FDA 510(k)

AGAR 8000 TENS

K-Number: K832851 · 1983-10-28

Decision Date1983-10-28

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

AGAR 8000 TENS is the device name listed in this FDA 510(k) record. The listed applicant is Kimed Industries, Inc.. It received FDA 510(k) clearance on 1983-10-28 under 510(k) number K832851. 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 8000 TENS?

AGAR 8000 TENS is a medical device that received FDA 510(k) clearance on 1983-10-28. The listed applicant is Kimed Industries, Inc.. The 510(k) number is K832851.

When did AGAR 8000 TENS receive FDA 510(k) clearance?

AGAR 8000 TENS received FDA 510(k) clearance on 1983-10-28, under 510(k) number K832851.

Who is the listed applicant for AGAR 8000 TENS?

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

What is the FDA product code for AGAR 8000 TENS?

The FDA product code for AGAR 8000 TENS is GZJ.

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 miniSublimed K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046Electrical 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.