Cleared Traditional

K770144 - RHEUMATOID HAND GYM

K770144 is the FDA 510(k) clearance for RHEUMATOID HAND GYM by Maddak, Inc.. It is a Class 1 Physical Medicine device (product code ION) cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K770144 · Maddak, Inc. · Physical Medicine device
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Jan 1977
Decision
4d
Days
Class 1
Risk

K770144 is an FDA 510(k) clearance for the RHEUMATOID HAND GYM. Classified as Exerciser, Non-measuring (product code ION), Class I - General Controls.

Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1977 after a review of 4 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 Maddak, Inc. devices

Submission Details

510(k) Number K770144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1977
Decision Date January 28, 1977
Days to Decision 4 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
111d faster than avg
Panel avg: 115d · This submission: 4d
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 24
Devices cleared under the same product code (ION) and FDA review panel - the closest regulatory comparables to K770144.
PUSH BALL INCLINE
K790530 · Maddak, Inc. · Apr 1979
FINGER EXERCISE BOARD
K772404 · Fred Sammons, Inc. · Feb 1978
EXERCISER, EXTENSOR WAND
K770436 · Maddak, Inc. · Apr 1977
SPIN-A-PULL
K761120 · Fred Sammons, Inc. · Dec 1976
SHORT INFLATED ROLLS
K761135 · Fred Sammons, Inc. · Dec 1976
CANOPY, PARACHUTE, BK-8110
K760304 · Fred Sammons, Inc. · Sep 1976