Cleared Traditional

PORT-A-TRAC (K861554) - FDA 510(k) Clearance

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

K861554 · Port-A-Trac Co. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1986
Decision
55d
Days
Class 2
Risk

K861554 is an FDA 510(k) clearance for the PORT-A-TRAC. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Port-A-Trac Co. (State College, US). The FDA issued a Cleared decision on June 19, 1986 after a review of 55 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 Port-A-Trac Co. devices

Submission Details

510(k) Number K861554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1986
Decision Date June 19, 1986
Days to Decision 55 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
60d faster than avg
Panel avg: 115d · This submission: 55d
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 K861554.
Ceragem Automatic Thermal Massager (CGM MB-2401)
K250266 · Ceragem Co., Ltd. · Jul 2025
AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
K241193 · Marzzan Lucas Jorge · Jan 2025
Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
K243644 · Ceragem Co., Ltd. · Jan 2025
Ceragem Automatic Thermal Massager (CGM-MB-1902)
K243355 · Ceragem Co., Ltd. · Nov 2024
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