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FDA 510(k)

KALMATE MODEL 3A

K-Number: K854476 · 1986-02-27

ApplicantMedical Technology Systems, Inc.
Decision Date1986-02-27
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KALMATE MODEL 3A is the device name listed in this FDA 510(k) record. The listed applicant is Medical Technology Systems, Inc.. It received FDA 510(k) clearance on 1986-02-27 under 510(k) number K854476. 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 KALMATE MODEL 3A?

KALMATE MODEL 3A is a medical device that received FDA 510(k) clearance on 1986-02-27. The listed applicant is Medical Technology Systems, Inc.. The 510(k) number is K854476.

When did KALMATE MODEL 3A receive FDA 510(k) clearance?

KALMATE MODEL 3A received FDA 510(k) clearance on 1986-02-27, under 510(k) number K854476.

Who is the listed applicant for KALMATE MODEL 3A?

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

What is the FDA product code for KALMATE MODEL 3A?

The FDA product code for KALMATE MODEL 3A 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 Medical Technology Systems, 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.

K063175IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION)

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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