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FDA 510(k)

POLAR CARE (MODEL 500/50000)

K-Number: K961855 · 1996-08-09

ApplicantBreg, Inc.
Decision Date1996-08-09
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

POLAR CARE (MODEL 500/50000) is the device name listed in this FDA 510(k) record. The listed applicant is Breg, Inc.. It received FDA 510(k) clearance on 1996-08-09 under 510(k) number K961855. 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 CARE (MODEL 500/50000)?

POLAR CARE (MODEL 500/50000) is a medical device that received FDA 510(k) clearance on 1996-08-09. The listed applicant is Breg, Inc.. The 510(k) number is K961855.

When did POLAR CARE (MODEL 500/50000) receive FDA 510(k) clearance?

POLAR CARE (MODEL 500/50000) received FDA 510(k) clearance on 1996-08-09, under 510(k) number K961855.

Who is the listed applicant for POLAR CARE (MODEL 500/50000)?

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 CARE (MODEL 500/50000)?

The FDA product code for POLAR CARE (MODEL 500/50000) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 16 devices →

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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