Cleared Traditional

PARAPODIUM (K791565) - FDA 510(k) Clearance

Class I Physical Medicine device.

K791565 · Physico-Medical Systems Corp. · Physical Medicine device
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Aug 1979
Decision
13d
Days
Class 1
Risk

K791565 is an FDA 510(k) clearance for the PARAPODIUM. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Physico-Medical Systems Corp. (Mchenry, US). The FDA issued a Cleared decision on August 28, 1979 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Physico-Medical Systems Corp. devices

Submission Details

510(k) Number K791565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1979
Decision Date August 28, 1979
Days to Decision 13 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IQI Orthosis, Limb Brace
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IQI Orthosis, Limb Brace

All 12
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K791565.
LIMB ORTHOSIS
K810443 · Fred Sammons, Inc. · Mar 1981
BAUER & BLACK RIGID WRIST BRACE
K801701 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1980
BK-1520-01 ECONOMY WRIST SUPPORT, CHILD
K801708 · Fred Sammons, Inc. · Aug 1980
CAST BRACE COMPONENTS
K791057 · 3M Company · Jun 1979
FOOT POSITIONER
K781206 · Fred Sammons, Inc. · Jul 1978
ORTHOSISES DEVICES
K780225 · Biomet, Inc. · Feb 1978