Cleared Traditional

K822906 - PHYSICAL MEDICINE & REHABILITATION EQUIP

K822906 is the FDA 510(k) clearance for PHYSICAL MEDICINE & REHABILITATION EQUIP by I-Rep, Inc.. It is a Class 1 Physical Medicine device (product code ION) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K822906 · I-Rep, Inc. · Physical Medicine device
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Oct 1982
Decision
16d
Days
Class 1
Risk

K822906 is an FDA 510(k) clearance for the PHYSICAL MEDICINE & REHABILITATION EQUIP. Classified as Exerciser, Non-measuring (product code ION), Class I - General Controls.

Submitted by I-Rep, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 15, 1982 after a review of 16 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 I-Rep, Inc. devices

Submission Details

510(k) Number K822906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1982
Decision Date October 15, 1982
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
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

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