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FDA 510(k)

PELTIERTHERAPY(C) HEAT/COLD TREATMENT

K-Number: K871112 · 1987-05-06

ApplicantHenley Intl.
Decision Date1987-05-06
Product CodeIMF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PELTIERTHERAPY(C) HEAT/COLD TREATMENT is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1987-05-06 under 510(k) number K871112. The device is classified under product code IMF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PELTIERTHERAPY(C) HEAT/COLD TREATMENT?

PELTIERTHERAPY(C) HEAT/COLD TREATMENT is a medical device that received FDA 510(k) clearance on 1987-05-06. The listed applicant is Henley Intl.. The 510(k) number is K871112.

When did PELTIERTHERAPY(C) HEAT/COLD TREATMENT receive FDA 510(k) clearance?

PELTIERTHERAPY(C) HEAT/COLD TREATMENT received FDA 510(k) clearance on 1987-05-06, under 510(k) number K871112.

Who is the listed applicant for PELTIERTHERAPY(C) HEAT/COLD TREATMENT?

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 PELTIERTHERAPY(C) HEAT/COLD TREATMENT?

The FDA product code for PELTIERTHERAPY(C) HEAT/COLD TREATMENT is IMF.

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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 DEVICESK926278STAIR CLIMBERK926279UPPER BODY EXERCISERK926287EXERCISE BICYCLEK926314HYDRA FITNESS MODEL 311 TOTAL POWERK926313COMPUTERIZED TESTING AND EXERCISE SYSTEMS

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Related Devices (Code: IMF)

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.

K900419CRYOTRON-UL30Henley Intl.

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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