Cleared Traditional

K771031 - STROKE SLING

K771031 is the FDA 510(k) clearance for STROKE SLING by Stat Medical Corp.. It is a Class 1 Physical Medicine device (product code ILI) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K771031 · Stat Medical Corp. · Physical Medicine device
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Jun 1977
Decision
18d
Days
Class 1
Risk

K771031 is an FDA 510(k) clearance for the STROKE SLING. Classified as Sling, Arm (product code ILI), Class I - General Controls.

Submitted by Stat Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on June 27, 1977 after a review of 18 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 Stat Medical Corp. devices

Submission Details

510(k) Number K771031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1977
Decision Date June 27, 1977
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
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 14
Devices cleared under the same product code (ILI) and FDA review panel - the closest regulatory comparables to K771031.
BAUER & BLACK ARM SLING W/DETACH. POUCH
K803212 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1981
TRIANGULAR BANDAGE CAT.#191
K802006 · Pollak (Intl.), Ltd. · Sep 1980
BK-6157-02 C.V.A SLING, MEDIUM&LARGE
K801713 · Fred Sammons, Inc. · Aug 1980
ECONOMY IMMOBILIZATION AND VELPEAN SLING
K760574 · Richard'S Medical Equip., Inc. · Oct 1976
BANDAGE, TRIANGULAR NO. 8068
K760250 · Johnson & Johnson Professionals, Inc. · Jul 1976