Cleared Traditional

K974626 - P.T. MACHINE

K974626 is an FDA 510(k) clearance for P.T. MACHINE, manufactured by Goodman, Goodman & Goodman. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K974626 · Goodman, Goodman & Goodman · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
57d
Days
Class 2
Risk

K974626 is an FDA 510(k) clearance for the P.T. MACHINE. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Goodman, Goodman & Goodman (Los Angelos, US). The FDA issued a Cleared decision on February 6, 1998 after a review of 57 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.

FDA 510(k) Submission Details - K974626

510(k) Number K974626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1997
Decision Date February 06, 1998
Days to Decision 57 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
59d faster than avg
Panel avg: 116d · This submission: 57d
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 51
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K974626.
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K974626 · P.T. MACHINE
Download PDF FDA Summary Goodman, Goodman & Go…