Cleared Traditional

K772404 - FINGER EXERCISE BOARD

K772404 is an FDA 510(k) clearance for FINGER EXERCISE BOARD, manufactured by Fred Sammons, Inc.. The device is a Class 1 Physical Medicine device with product code ION cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K772404 · Fred Sammons, Inc. · Physical Medicine device
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Feb 1978
Decision
48d
Days
Class 1
Risk

K772404 is an FDA 510(k) clearance for the FINGER EXERCISE BOARD. 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 February 13, 1978 after a review of 48 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

FDA 510(k) Submission Details - K772404

510(k) Number K772404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1977
Decision Date February 13, 1978
Days to Decision 48 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
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

ION Device Classification - Class 1, General Controls

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 24
Devices cleared under the same product code (ION) and FDA review panel - the closest regulatory comparables to K772404.
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
PUSH BALL INCLINE
K790530 · Maddak, Inc. · Apr 1979
EXERCISER, EXTENSOR WAND
K770436 · Maddak, Inc. · Apr 1977
RHEUMATOID HAND GYM
K770144 · Maddak, Inc. · Jan 1977
SPIN-A-PULL
K761120 · Fred Sammons, Inc. · Dec 1976