Cleared Traditional

K922980 - 745-M (MAGNUM) (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922980 · Tri W-G, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
21d
Days
Class 2
Risk

K922980 is an FDA 510(k) clearance for the 745-M (MAGNUM). Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on July 13, 1992 after a review of 21 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 Tri W-G, Inc. devices

Submission Details

510(k) Number K922980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1992
Decision Date July 13, 1992
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 65
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K922980.
Ceragem Automatic Thermal Massager (CGM MB-2401)
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AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
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Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
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Ceragem Automatic Thermal Massager (CGM-MB-1902)
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N7-S
K240168 · Nuga Medical Co., Ltd. · Sep 2024
Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
K220572 · Ceragem Co., Ltd. · Jun 2022