Cleared Traditional

DELUXE TRACTION EXERCISE GLOVE BK5035 (K831544) - FDA 510(k) Clearance

Class I Physical Medicine device.

K831544 · Fred Sammons, Inc. · Physical Medicine device
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Jun 1983
Decision
43d
Days
Class 1
Risk

K831544 is an FDA 510(k) clearance for the DELUXE TRACTION EXERCISE GLOVE BK5035. Classified as Components, Exercise (product code IOD), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1983 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5350 - 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 K831544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1983
Decision Date June 24, 1983
Days to Decision 43 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
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IOD Components, Exercise
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5350
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 - IOD Components, Exercise

Devices cleared under the same product code (IOD) and FDA review panel - the closest regulatory comparables to K831544.
SURGICAL TUBING
K823648 · Fred Sammons, Inc. · Jan 1983
SOLID WOOD CONE
K823600 · Fred Sammons, Inc. · Dec 1982
COLOR CODED WEIGHT CUFFS
K813632 · Fred Sammons, Inc. · Jan 1982
SANDBAGS, VARIOUS WEIGHTS
K772414 · Fred Sammons, Inc. · Feb 1978
HAND SCREW CLAMP
K761118 · Fred Sammons, Inc. · Dec 1976
SHEET METAL CLAMP
K761119 · Fred Sammons, Inc. · Dec 1976