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FDA 510(k)

CONCEPT CCT-5200, THERMAL THERAPY SYSTEM

K-Number: K884255 · 1988-11-08

ApplicantConcept, Inc.
Decision Date1988-11-08
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CONCEPT CCT-5200, THERMAL THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1988-11-08 under 510(k) number K884255. 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 CCT-5200, THERMAL THERAPY SYSTEM?

CONCEPT CCT-5200, THERMAL THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1988-11-08. The listed applicant is Concept, Inc.. The 510(k) number is K884255.

When did CONCEPT CCT-5200, THERMAL THERAPY SYSTEM receive FDA 510(k) clearance?

CONCEPT CCT-5200, THERMAL THERAPY SYSTEM received FDA 510(k) clearance on 1988-11-08, under 510(k) number K884255.

Who is the listed applicant for CONCEPT CCT-5200, THERMAL THERAPY SYSTEM?

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

What is the FDA product code for CONCEPT CCT-5200, THERMAL THERAPY SYSTEM?

The FDA product code for CONCEPT CCT-5200, THERMAL THERAPY SYSTEM is ILO.

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Other records listing Concept, 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.

K912640CONCEPT ENDOSTEAL FIXATION DEVICEK912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

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Related Devices (Code: ILO)

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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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