Cleared Traditional

K861352 - R1698,R1701,R1215,R1700 & R860 POWERED TABLES

K861352 is an FDA 510(k) clearance for R1698, manufactured by Tri W-G, Inc.. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K861352 · Tri W-G, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
25d
Days
Class 1
Risk

K861352 is an FDA 510(k) clearance for the R1698,R1701,R1215,R1700 & R860 POWERED TABLES. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 25 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.

FDA 510(k) Submission Details - K861352

510(k) Number K861352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1986
Decision Date May 02, 1986
Days to Decision 25 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 116d · This submission: 25d
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 101
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K861352.
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K864817 · S & W Enterprises, Inc. · Jan 1987
ELECTRA CHIROPRACT/EQUIP TABLE ELECTRA I&STATIONAR
K854635 · Electra Equipment , Ltd. · Jan 1986
REHABILITATION TABLES
K854947 · I-Rep, Inc. · Jan 1986
THERA-TRONIC THERAPEUTIC TREATMENT TABLE
K852651 · Rwm Co. · Sep 1985
K861352 · R1698,R1701,R1215,R1700 & R860 POWERED TABLES
Download PDF Tri W-G, Inc.