Cleared Traditional

K812477 - ARM SLING

K812477 is the FDA 510(k) clearance for ARM SLING by Maddak, Inc.. It is a Class 1 Physical Medicine device (product code ILI) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K812477 · Maddak, Inc. · Physical Medicine device
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Sep 1981
Decision
14d
Days
Class 1
Risk

K812477 is an FDA 510(k) clearance for the ARM SLING, POUCH TYPE. Classified as Sling, Arm (product code ILI), Class I - General Controls.

Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1981 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3640 - 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 Maddak, Inc. devices

Submission Details

510(k) Number K812477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1981
Decision Date September 14, 1981
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ILI Sling, Arm
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3640
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 - ILI Sling, Arm

All 12
Devices cleared under the same product code (ILI) and FDA review panel - the closest regulatory comparables to K812477.
VARIOUS ARM SLING
K823808 · Danek Medical, Inc. · Jan 1983
A.C. SPLINT
K823810 · Danek Medical, Inc. · Jan 1983
ORTHOPEDIC SOFT GOODS
K820590 · Abco Dealers, Inc. · Mar 1982
MADDACOMFORT SLING
K812478 · Maddak, Inc. · Sep 1981
LIMB HOLDER ARM SLING
K812480 · Maddak, Inc. · Sep 1981
ARM SLINGS
K812345 · Fred Sammons, Inc. · Sep 1981