Cleared Traditional

K854635 - ELECTRA CHIROPRACT/EQUIP TABLE ELECTRA ...

K854635 is the FDA 510(k) clearance for ELECTRA CHIROPRACT/EQUIP TABLE ELECTRA ... by Electra Equipment , Ltd.. It is a Class 1 Physical Medicine device (product code INQ) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K854635 · Electra Equipment , Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1986
Decision
45d
Days
Class 1
Risk

K854635 is an FDA 510(k) clearance for the ELECTRA CHIROPRACT/EQUIP TABLE ELECTRA I&STATIONAR. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Electra Equipment , Ltd. (Rockford, US). The FDA issued a Cleared decision on January 3, 1986 after a review of 45 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 Electra Equipment , Ltd. devices

Submission Details

510(k) Number K854635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1985
Decision Date January 03, 1986
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 17
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K854635.
POWER PODIATRY CHAIR/TABLE #414, #416 & #417
K894017 · Midmark Corp. · Jul 1989
HLE-1000 HIGH/LOW TREATMENT TABLE
K883659 · Rich-Mar Corp. · Oct 1988
R1698,R1701,R1215,R1700 & R860 POWERED TABLES
K861352 · Tri W-G, Inc. · May 1986
HI-LO TILT TABLE 625
K850377 · Tri W-G, Inc. · May 1985
MODELS 841,842,843,851,852 & 853 ELEVATING TRACTIO
K844712 · Tri W-G, Inc. · Mar 1985
MOBILIZATIOIN TABLE
K841594 · Chattanooga Group, Inc. · May 1984