Cleared Traditional

K950364 - CARDON PHYSICAL THERAPY TABLES R27635

K950364 is an FDA 510(k) clearance for CARDON PHYSICAL THERAPY TABLES R27635, manufactured by Cardon Rehabilitation Products, Inc.. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K950364 · Cardon Rehabilitation Products, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
11d
Days
Class 1
Risk

K950364 is an FDA 510(k) clearance for the CARDON PHYSICAL THERAPY TABLES R27635. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Cardon Rehabilitation Products, Inc. (Niagara Falls, US). The FDA issued a Cleared decision on February 10, 1995 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3760 - 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 Cardon Rehabilitation Products, Inc. devices

FDA 510(k) Submission Details - K950364

510(k) Number K950364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1995
Decision Date February 10, 1995
Days to Decision 11 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
104d faster than avg
Panel avg: 115d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

INQ Device Classification - Class 1, General Controls

Product Code INQ Table, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3760
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - INQ Table, Powered

All 48
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K950364.
CARDON PHYSICAL THERAPY TABLE R28575
K950361 · Cardon Rehabilitation Products, Inc. · Feb 1995
CARDON PHYSICAL THERAPY TABLE R27114 AND R27642
K950362 · Cardon Rehabilitation Products, Inc. · Feb 1995
CARDONPHYSICAL THERAPY TABLE R27110
K950363 · Cardon Rehabilitation Products, Inc. · Feb 1995
MODEL 747 AND 747-30 EXAM/TREATMENT TABLE
K941720 · Tri W-G, Inc. · May 1994
TREATMENT TABLE MODIFICATION
K936303 · Tri W-G, Inc. · Mar 1994
POWERMATIC MAT PLATFORM
K933578 · Medical Device Inspection Co., Inc. · Nov 1993