Cleared Traditional

K821637 - WIRE-FOAM MP FLEXION SPRING

K821637 is an FDA 510(k) clearance for WIRE-FOAM MP FLEXION SPRING, manufactured by Fred Sammons, Inc.. The device is a Class 1 Physical Medicine device with product code ILH cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K821637 · Fred Sammons, Inc. · Physical Medicine device
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Jun 1982
Decision
8d
Days
Class 1
Risk

K821637 is an FDA 510(k) clearance for the WIRE-FOAM MP FLEXION SPRING. Classified as Splint, Hand, And Components (product code ILH), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 11, 1982 after a review of 8 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

FDA 510(k) Submission Details - K821637

510(k) Number K821637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1982
Decision Date June 11, 1982
Days to Decision 8 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
107d faster than avg
Panel avg: 115d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

ILH Device Classification - Class 1, General Controls

Product Code ILH Splint, Hand, And Components
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 - ILH Splint, Hand, And Components

All 27
Devices cleared under the same product code (ILH) and FDA review panel - the closest regulatory comparables to K821637.
STAX FINGER SPLINTS
K823393 · Orthopedic Systems, Inc. · Dec 1982
WRIST SPLING & FOREARM SPLINT
K823165 · Warm & Form, Orthopedic Materials · Nov 1982
SOFT ULNAR DEVIATION SPLINTS
K821635 · Fred Sammons, Inc. · Jun 1982
VELCRO FINGER/TOE SPLINT
K812654 · Maddak, Inc. · Sep 1981
VELCRO SPLINT STRAP FASTENERS
K812655 · Maddak, Inc. · Sep 1981
HAND SPLINTS & COMPONENTS
K812349 · Fred Sammons, Inc. · Sep 1981