Cleared Traditional

NON-MEASURING EXERCISERS (K812351) - FDA 510(k) Clearance

Class I Physical Medicine device.

K812351 · Fred Sammons, Inc. · Physical Medicine device
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Sep 1981
Decision
27d
Days
Class 1
Risk

K812351 is an FDA 510(k) clearance for the NON-MEASURING EXERCISERS. Classified as Exerciser, Non-measuring (product code ION), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1981 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5370 - 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 K812351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1981
Decision Date September 14, 1981
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ION Exerciser, Non-measuring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5370
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 - ION Exerciser, Non-measuring

All 17
Devices cleared under the same product code (ION) and FDA review panel - the closest regulatory comparables to K812351.
VISCO HANDEX-VARIOUS MODELS
K821855 · Fred Sammons, Inc. · Jul 1982
BK-5305 MULTIPLE HAND GRID
K821857 · Fred Sammons, Inc. · Jul 1982
MODELING COMPOUND AND FOAM EXERCISER
K813633 · Fred Sammons, Inc. · Jan 1982
NON-MEASURING EXERCISERS
K810444 · Fred Sammons, Inc. · Mar 1981
BK-5315-01 FOAM HAND EXERCISER, SMALL
K801710 · Fred Sammons, Inc. · Aug 1980
COLOR CODED PUTTY SOFT, REGULAR & FIRM
K800017 · Fred Sammons, Inc. · Jan 1980