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FDA 510(k)

CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM

K-Number: K911943 · 1991-07-19

ApplicantBurke, Inc.
Decision Date1991-07-19
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Burke, Inc.. It received FDA 510(k) clearance on 1991-07-19 under 510(k) number K911943. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM?

CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1991-07-19. The listed applicant is Burke, Inc.. The 510(k) number is K911943.

When did CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM receive FDA 510(k) clearance?

CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM received FDA 510(k) clearance on 1991-07-19, under 510(k) number K911943.

Who is the listed applicant for CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM?

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

What is the FDA product code for CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM?

The FDA product code for CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM is ILO.

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Other records listing Burke, 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.

K061912FUSIONK023961SCOUT BOSSK982158SCOUTK965123PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)K893706COLD/HOT FLUID RADIATION PAD NEUTECHK834506PACESAVER & SCOUT

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Related Devices (Code: ILO)

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.

K213097Armory MotionPain Management Technologies, Inc.K083008COOLSKINElbio Co., Ltd.K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.K072152JUNIPER CLN1 DERMAL COOLING DEVICEJuniper Medical, Inc.K070402MODIFICATION TO POLAR CARE 500Breg, Inc.K040317IVC SYSTEMMark H. Friedman

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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