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Gaymar Industries, Inc.

United StatesFDA applicant, unverified

Devices
27
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Gaymar Industries, Inc. makes

Gaymar Industries manufactures medical devices for patient temperature management, pressure therapy, and mobility support. Their portfolio includes systems for inducing hypothermia or hyperthermia, such as the MEDI-THERM series, as well as sequential pressure cuffs and localized temperature therapy pumps like the T-PUMP. They also produce soft care cushions and gel chairs for pressure relief, alternating pressure pad systems, and mobile patient weighing stations.

The company’s devices are classified under FDA categories Class I and Class II, with regulatory clearance obtained through the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue27

Newest first, rows 1-27 of 27

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  • Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900 Ref K100585

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sequential Pressure Cuff Ref K771083

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sof. Press Epc 51 System Ref K963067

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • T-Pump Localized Temperature Therapy Pump Ref K073675

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • T-Pump, Temperature - Therapy Pump Ref K760804

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Lifestyle Sof. Care Gel Chair Cushion Ref K882012

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Air-Flo Alternating Pressure Pad System Ref K780906

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cla-1400 System Ref K914851

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • T-Pad Ref K760527

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Weighing Station, Mobile Patient Ref K760545

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Sof. Care Cushion & Sof-Care Cushion Cover Ref K851027

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • TC2000 Power Unit And Accessories Ref K930345

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Spr Plus Ii Overlay System (CL250/CL212 Ref K961854

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Neo-Wave System Ref K810543

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Clini-Care + Pressure Ulcer Treatment System Ref K882092

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mul-T-Pad Ref K760706

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Medi-Therm (Mta-5900) & Detachable Hoses Ref K912051

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tc 3000 Ref K942881

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Scm-3 And Accessories Ref K914921

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Clinidyne Rotational Therapy Mattress System Ref K962788

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Neo Shield Ref K852943

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gastric Lavage Kit Ref K780471

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mul-T-Pad Ref K832819

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Medi-Therm Ref K800812

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mul-T-Blanket Ref K832820

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tc-1000, Tc-1050 System Ref K914805

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pad, Polyether Foam, Open Cell Ref K760315

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-27 of 27

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Gaymar Industries, Inc., initiated on 2004-10-25. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2004

    • 25 Oct 2004 Z-0260-05 Unclassified (pre-2012) Terminated Design control/validation deficiencies. Distribution: The units were sold to the own-label distributor, who in turn sold 8 units to two hospitals in Nebraska and Hawaii.

Frequently asked questions

How many devices does Gaymar Industries, Inc. have in the registry?

The registry currently lists 27 devices for Gaymar Industries, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gaymar Industries, Inc.'s devices?

Among its 27 most recently registered devices, Gaymar Industries, Inc. has devices listed in FDA 510(k) (27 devices).

What risk classes do Gaymar Industries, Inc.'s devices fall under?

Among its 27 most recently registered devices, the classes recorded for Gaymar Industries, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Gaymar Industries, Inc.?

FDA recall records list 1 recall initiated by Gaymar Industries, Inc., the most recent initiated on 25 Oct 2004. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Gaymar Industries, Inc. in the registry?

The most recently registered devices listed for Gaymar Industries, Inc. include MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900, SEQUENTIAL PRESSURE CUFF, SOF. PRESS EPC 51 SYSTEM and T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP.

Generated automatically from registry data and not verified by a human reviewer.