Cleared Traditional

OBJECTS PRECISION HANDLING TEST KIT (K781350) - FDA 510(k) Clearance

Class I Physical Medicine device.

K781350 · Metro. Hospital & Health Center · Physical Medicine device
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Oct 1978
Decision
71d
Days
Class 1
Risk

K781350 is an FDA 510(k) clearance for the OBJECTS PRECISION HANDLING TEST KIT. Classified as Exerciser, Non-measuring (product code ION), Class I - General Controls.

Submitted by Metro. Hospital & Health Center (Mchenry, US). The FDA issued a Cleared decision on October 17, 1978 after a review of 71 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 Metro. Hospital & Health Center devices

Submission Details

510(k) Number K781350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1978
Decision Date October 17, 1978
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
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 18
Devices cleared under the same product code (ION) and FDA review panel - the closest regulatory comparables to K781350.
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
FINGER EXERCISE BOARD
K772404 · Fred Sammons, Inc. · Feb 1978
SPIN-A-PULL
K761120 · Fred Sammons, Inc. · Dec 1976
SHORT INFLATED ROLLS
K761135 · Fred Sammons, Inc. · Dec 1976