Cleared Traditional

K924293 - HERITAGE 10

K924293 is an FDA 510(k) clearance for HERITAGE 10, manufactured by Tjn Manufacturing,Inc.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K924293 · Tjn Manufacturing,Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
273d
Days
Class 2
Risk

K924293 is an FDA 510(k) clearance for the HERITAGE 10. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Tjn Manufacturing,Inc. (Davenport, US). The FDA issued a Cleared decision on May 26, 1993 after a review of 273 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Tjn Manufacturing,Inc. devices

FDA 510(k) Submission Details - K924293

510(k) Number K924293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1992
Decision Date May 26, 1993
Days to Decision 273 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 115d · This submission: 273d
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 33
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K924293.
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K930259 · Biodan Medical Systems, Ltd. · Mar 1993
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K922980 · Tri W-G, Inc. · Jul 1992