Cleared Traditional

K830400 - MADDATRAINER HAND EXERCISER

K830400 is an FDA 510(k) clearance for MADDATRAINER HAND EXERCISER, manufactured by Maddak, Inc.. The device is a Class 1 Physical Medicine device with product code ION cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K830400 · Maddak, Inc. · Physical Medicine device
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Mar 1983
Decision
30d
Days
Class 1
Risk

K830400 is an FDA 510(k) clearance for the MADDATRAINER HAND EXERCISER. 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 March 9, 1983 after a review of 30 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.

FDA 510(k) Submission Details - K830400

510(k) Number K830400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1983
Decision Date March 09, 1983
Days to Decision 30 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
86d faster than avg
Panel avg: 116d · This submission: 30d
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 42
Devices cleared under the same product code (ION) and FDA review panel - the closest regulatory comparables to K830400.
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K830400 · MADDATRAINER HAND EXERCISER
Download PDF Maddak, Inc.