Cleared Traditional

K925563 - FT MODEL TABLE W/ELECTRIC HI LO OPTION E

K925563 is an FDA 510(k) clearance for FT MODEL TABLE W/ELECTRIC HI LO OPTION E, manufactured by Pro Med Mfg., Inc.. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K925563 · Pro Med Mfg., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
204d
Days
Class 1
Risk

K925563 is an FDA 510(k) clearance for the FT MODEL TABLE W/ELECTRIC HI LO OPTION E. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Pro Med Mfg., Inc. (Blaine, US). The FDA issued a Cleared decision on May 26, 1993 after a review of 204 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Pro Med Mfg., Inc. devices

FDA 510(k) Submission Details - K925563

510(k) Number K925563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1992
Decision Date May 26, 1993
Days to Decision 204 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 115d · This submission: 204d
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 49
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K925563.
POWERMATIC EXAMINATION TABLE
K933577 · Medical Device Inspection Co., Inc. · Sep 1993
MODEL T4501,T4502,T4503,T4504,T4504 TILT TABLE
K932746 · Tri W-G, Inc. · Jul 1993
THE HILL ADJUSTABLE HA90
K931832 · Hill Laboratories Co. · Jun 1993
MODELS 642 & 643 TILT EXAM/TREATMENT TABLE
K930802 · Tri W-G, Inc. · Mar 1993
MDL 29001 MEDI ELEC-MECH TILT EXAM/TREATMENT TABLE
K925594 · Tri W-G, Inc. · Feb 1993
MODEL 600 MEDICAL TREATMENT TABLE
K923325 · Tri W-G, Inc. · Jul 1992