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FDA 510(k)

CURAPULS 419 DIATHERMY UNIT

K-Number: K861248 · 1986-05-30

ApplicantHenley Intl.
Decision Date1986-05-30
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CURAPULS 419 DIATHERMY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1986-05-30 under 510(k) number K861248. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CURAPULS 419 DIATHERMY UNIT?

CURAPULS 419 DIATHERMY UNIT is a medical device that received FDA 510(k) clearance on 1986-05-30. The listed applicant is Henley Intl.. The 510(k) number is K861248.

When did CURAPULS 419 DIATHERMY UNIT receive FDA 510(k) clearance?

CURAPULS 419 DIATHERMY UNIT received FDA 510(k) clearance on 1986-05-30, under 510(k) number K861248.

Who is the listed applicant for CURAPULS 419 DIATHERMY UNIT?

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

What is the FDA product code for CURAPULS 419 DIATHERMY UNIT?

The FDA product code for CURAPULS 419 DIATHERMY UNIT is IMJ.

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Other records listing Henley Intl. 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.

K943449NEUROLOGICAL DIAGNOSTIC DEVICESK926279UPPER BODY EXERCISERK926278STAIR CLIMBERK926287EXERCISE BICYCLEK926314HYDRA FITNESS MODEL 311 TOTAL POWERK926313COMPUTERIZED TESTING AND EXERCISE SYSTEMS

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Related Devices (Code: IMJ)

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.

K252963BTL-899TTBTL Industries, Inc.K250376ViVYViatherm Therapeutics, LLCK243112Curapuls 670Enraf-Nonius, B.V.K223620Reprieve by RegenesisTMRegenesis Biomedical, Inc.K182363BTL-703BTL Industries, Inc.K173300ViaTherm BOOSTViatherm Therapeutics, LLC

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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