Cleared Traditional

K871802 - MODEL K210 AND K211 FLUIDOTHERAPY UNITS

K871802 is an FDA 510(k) clearance for MODEL K210 AND K211 FLUIDOTHERAPY UNITS, manufactured by Henley Intl.. The device is a Class 2 Physical Medicine device with product code LSB cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K871802 · Henley Intl. · Physical Medicine device
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Sep 1987
Decision
119d
Days
Class 2
Risk

K871802 is an FDA 510(k) clearance for the MODEL K210 AND K211 FLUIDOTHERAPY UNITS. Classified as Unit, Fluidotherapy (product code LSB), Class II - Special Controls.

Submitted by Henley Intl. (Houston, US). The FDA issued a Cleared decision on September 4, 1987 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5100 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Henley Intl. devices

FDA 510(k) Submission Details - K871802

510(k) Number K871802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1987
Decision Date September 04, 1987
Days to Decision 119 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LSB Device Classification - Class 2, Special Controls

Product Code LSB Unit, Fluidotherapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.