Cleared Traditional

K001361 - JILCO TRACTION-FLEXION CHAIR

K001361 is an FDA 510(k) clearance for JILCO TRACTION-FLEXION CHAIR, manufactured by Jilco Enterprises. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K001361 · Jilco Enterprises · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
82d
Days
Class 2
Risk

K001361 is an FDA 510(k) clearance for the JILCO TRACTION-FLEXION CHAIR. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Jilco Enterprises (Grandview, US). The FDA issued a Cleared decision on July 19, 2000 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5900 - 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 - K001361

510(k) Number K001361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2000
Decision Date July 19, 2000
Days to Decision 82 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
34d faster than avg
Panel avg: 116d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITH Device Classification - Class 2, Special Controls

Product Code ITH Equipment, Traction, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5900
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 - ITH Equipment, Traction, Powered

All 70
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K001361.
DRX 2000
K010292 · Axiom Worldwide, Inc. · May 2001
3D ACTIVETRAC
K001712 · The Saunders Group · Aug 2000
SPINA SYSTEM
K002260 · North American Medical Corporation (Nam) · Aug 2000
SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM
K001296 · Cavendish Scott, Inc. · Jul 2000
AMT THERAPEUTIC TABLE, MODEL 748AMT
K001401 · Amt Mfg., Inc. · Jul 2000
DYNATRON 900
K993919 · Dynatronics Corp. · Jan 2000
K001361 · JILCO TRACTION-FLEXION CHAIR
Download PDF FDA Summary Jilco Enterprises