Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)

K-Number: K940858 · 1994-07-12

ApplicantInnovation Sports, Inc.
Decision Date1994-07-12
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) is the device name listed in this FDA 510(k) record. The listed applicant is Innovation Sports, Inc.. It received FDA 510(k) clearance on 1994-07-12 under 510(k) number K940858. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)?

THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) is a medical device that received FDA 510(k) clearance on 1994-07-12. The listed applicant is Innovation Sports, Inc.. The 510(k) number is K940858.

When did THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) receive FDA 510(k) clearance?

THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) received FDA 510(k) clearance on 1994-07-12, under 510(k) number K940858.

Who is the listed applicant for THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)?

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

What is the FDA product code for THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)?

The FDA product code for THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) 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 Innovation Sports, 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.

K831310BRACE C.T.

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.

↑