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FDA 510(k)

POLAR PAD (STERILE)

K-Number: K920581 · 1992-03-20

ApplicantBreg, Inc.
Decision Date1992-03-20
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

POLAR PAD (STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Breg, Inc.. It received FDA 510(k) clearance on 1992-03-20 under 510(k) number K920581. 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 POLAR PAD (STERILE)?

POLAR PAD (STERILE) is a medical device that received FDA 510(k) clearance on 1992-03-20. The listed applicant is Breg, Inc.. The 510(k) number is K920581.

When did POLAR PAD (STERILE) receive FDA 510(k) clearance?

POLAR PAD (STERILE) received FDA 510(k) clearance on 1992-03-20, under 510(k) number K920581.

Who is the listed applicant for POLAR PAD (STERILE)?

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

What is the FDA product code for POLAR PAD (STERILE)?

The FDA product code for POLAR PAD (STERILE) is ILO.

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 Breg, 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.

K183702Polar Care WaveK070402MODIFICATION TO POLAR CARE 500K041714E-PAIN CAREK020988PAIN CARE 4200K013928PAIN CARE 3200K003611PAIN CARE MULTI-PORT CATHETER, MODEL 2000L

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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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