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FDA 510(k)

HTP-1500 LOCALIZED HEAT THERAPY PUMP

K-Number: K970197 · 1997-09-10

ApplicantAdroit Medical Systems, Inc.
Decision Date1997-09-10
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HTP-1500 LOCALIZED HEAT THERAPY PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Adroit Medical Systems, Inc.. It received FDA 510(k) clearance on 1997-09-10 under 510(k) number K970197. 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 HTP-1500 LOCALIZED HEAT THERAPY PUMP?

HTP-1500 LOCALIZED HEAT THERAPY PUMP is a medical device that received FDA 510(k) clearance on 1997-09-10. The listed applicant is Adroit Medical Systems, Inc.. The 510(k) number is K970197.

When did HTP-1500 LOCALIZED HEAT THERAPY PUMP receive FDA 510(k) clearance?

HTP-1500 LOCALIZED HEAT THERAPY PUMP received FDA 510(k) clearance on 1997-09-10, under 510(k) number K970197.

Who is the listed applicant for HTP-1500 LOCALIZED HEAT THERAPY PUMP?

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

What is the FDA product code for HTP-1500 LOCALIZED HEAT THERAPY PUMP?

The FDA product code for HTP-1500 LOCALIZED HEAT THERAPY PUMP 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 Adroit Medical Systems, 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.

K073712SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100K973981SAFEPASS STERILIZATION POUCHK962983STERILE SOFT-TEMPK921920SOFT-TEMPK921928SOFT-COVER

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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