Cleared Traditional

K861348 - R1361 & R1372 MEASURED EXERCISE EQUIPMENT

K861348 is an FDA 510(k) clearance for R1361 & R1372 MEASURED EXERCISE EQUIPMENT, manufactured by Tri W-G, Inc.. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K861348 · Tri W-G, Inc. · Physical Medicine device
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May 1986
Decision
25d
Days
Class 2
Risk

K861348 is an FDA 510(k) clearance for the R1361 & R1372 MEASURED EXERCISE EQUIPMENT. Classified as Exerciser, Measuring (product code ISD), Class II - Special 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 890.5360 - 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 - K861348

510(k) Number K861348 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. No clinical trials required.

ISD Device Classification - Class 2, Special Controls

Product Code ISD Exerciser, Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
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 - ISD Exerciser, Measuring

All 60
Devices cleared under the same product code (ISD) and FDA review panel - the closest regulatory comparables to K861348.
DISCIPLINE I
K870872 · Physio Systems, Inc. · Mar 1987
APPLIDYN
K864581 · Grandcor Medical Systems · Jan 1987
PULSESTAR EXERCISE BIKE
K863884 · Battle Creek Equipment Co. · Oct 1986
REMOTE SPEED CONTROL
K851946 · Th Charters, Inc. · Jul 1985
TORQUE FEEDBACK METER
K851967 · Th Charters, Inc. · Jul 1985
LODE MODEL CORIVAL ERGOMETER
K851097 · Lode Corp. · Jun 1985
K861348 · R1361 & R1372 MEASURED EXERCISE EQUIPMENT
Download PDF Tri W-G, Inc.