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FDA 510(k)

MODEL K210 AND K211 FLUIDOTHERAPY UNITS

K-Number: K871802 · 1987-09-04

ApplicantHenley Intl.
Decision Date1987-09-04
Product CodeLSB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODEL K210 AND K211 FLUIDOTHERAPY UNITS is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1987-09-04 under 510(k) number K871802. The device is classified under product code LSB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL K210 AND K211 FLUIDOTHERAPY UNITS?

MODEL K210 AND K211 FLUIDOTHERAPY UNITS is a medical device that received FDA 510(k) clearance on 1987-09-04. The listed applicant is Henley Intl.. The 510(k) number is K871802.

When did MODEL K210 AND K211 FLUIDOTHERAPY UNITS receive FDA 510(k) clearance?

MODEL K210 AND K211 FLUIDOTHERAPY UNITS received FDA 510(k) clearance on 1987-09-04, under 510(k) number K871802.

Who is the listed applicant for MODEL K210 AND K211 FLUIDOTHERAPY UNITS?

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 MODEL K210 AND K211 FLUIDOTHERAPY UNITS?

The FDA product code for MODEL K210 AND K211 FLUIDOTHERAPY UNITS is LSB.

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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: LSB)

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.

K011768THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202Thermo-Electric Co.K011243CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000Chattanooga Group, Inc.K896817MODEL T11 FLUIDOTHERAPY UNITHenley 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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