Cleared Traditional

K811490 - FOREARM & KNEE STRAPS

K811490 is the FDA 510(k) clearance for FOREARM & KNEE STRAPS by Fred Sammons, Inc.. It is a Class 1 Physical Medicine device (product code IQI) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K811490 · Fred Sammons, Inc. · Physical Medicine device
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Jun 1981
Decision
17d
Days
Class 1
Risk

K811490 is an FDA 510(k) clearance for the FOREARM & KNEE STRAPS. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 17 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 Fred Sammons, Inc. devices

Submission Details

510(k) Number K811490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1981
Decision Date June 12, 1981
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
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 15
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K811490.
ADJUSTABLE POLYCENTRIC ELBOW HINGE
K831542 · Fred Sammons, Inc. · Jun 1983
ORTHOTIC FABRICATION ACCESSORIES
K821640 · Fred Sammons, Inc. · Jun 1982
OBTHOSES
K821641 · Fred Sammons, Inc. · Jun 1982
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