Cleared Traditional

K881902 - HEALTHTRONIC OMEGA TRAC

K881902 is an FDA 510(k) clearance for HEALTHTRONIC OMEGA TRAC, manufactured by Healthtronics Surgical Services, Inc.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K881902 · Healthtronics Surgical Services, Inc. · Physical Medicine device
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Jun 1988
Decision
47d
Days
Class 2
Risk

K881902 is an FDA 510(k) clearance for the HEALTHTRONIC OMEGA TRAC. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Healthtronics Surgical Services, Inc. (Rancho Cordova, US). The FDA issued a Cleared decision on June 22, 1988 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5880 - 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 Healthtronics Surgical Services, Inc. devices

FDA 510(k) Submission Details - K881902

510(k) Number K881902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1988
Decision Date June 22, 1988
Days to Decision 47 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
68d faster than avg
Panel avg: 115d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFB Device Classification - Class 2, Special Controls

Product Code JFB Table, Physical Therapy, Multi Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - JFB Table, Physical Therapy, Multi Function

All 16
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K881902.
745-M (MAGNUM)
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IST-200 INTERSEGMENTAL TRACTION TABLE
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HI-LO TABLE, MODEL 820-05
K882917 · Tri W-G, Inc. · Jul 1988
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AUTOTRACTION TABLE
K844233 · Chattanooga Group, Inc. · Dec 1984
PDB II VIBRATING DRAINAGE BED
K843572 · Invacare Corp. · Nov 1984