Cleared Traditional

K922980 - 745-M (MAGNUM)

K922980 is an FDA 510(k) clearance for 745-M (MAGNUM), manufactured by Tri W-G, Inc.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 21-day FDA review.

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

FDA 510(k) Submission Details - K922980

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
Combination Product No
PCCP Authorized No
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.

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 15
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K922980.
Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
K202937 · Ceragem Co., Ltd. · Mar 2021
Ceragem Automatic Thermal Massager, Model CGM-MB-1901
K202113 · Ceragem Co., Ltd. · Mar 2021
TRUE-TRAC, STRATUS
K926316 · Henley Intl. · Mar 1993
IST-200 INTERSEGMENTAL TRACTION TABLE
K900304 · Chattanooga Group, Inc. · Apr 1990
HI-LO TABLE, MODEL 820-05
K882917 · Tri W-G, Inc. · Jul 1988
KINETIC AUTO TECHNIC K.A.T. TABLE
K851328 · Buckman Co., Inc. · Jul 1985