Cleared Traditional

SHORT INFLATED ROLLS (K761135) - FDA 510(k) Clearance

Class I Physical Medicine device.

K761135 · Fred Sammons, Inc. · Physical Medicine device
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Dec 1976
Decision
13d
Days
Class 1
Risk

K761135 is an FDA 510(k) clearance for the SHORT INFLATED ROLLS. 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 December 2, 1976 after a review of 13 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 K761135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1976
Decision Date December 02, 1976
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
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 K761135.
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
CANOPY, PARACHUTE, BK-8110
K760304 · Fred Sammons, Inc. · Sep 1976
BALLOONS, BK-8112, 8114
K760305 · Fred Sammons, Inc. · Sep 1976