Cleared Traditional

K831473 - ULTRA PULSATOR MF

K831473 is the FDA 510(k) clearance for ULTRA PULSATOR MF by Medelco , Ltd.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K831473 · Medelco , Ltd. · Physical Medicine device
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Jul 1983
Decision
81d
Days
Class 2
Risk

K831473 is an FDA 510(k) clearance for the ULTRA PULSATOR MF. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Medelco , Ltd. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1983 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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 Medelco , Ltd. devices

Submission Details

510(k) Number K831473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1983
Decision Date July 26, 1983
Days to Decision 81 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
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 - IPF Stimulator, Muscle, Powered

All 150
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K831473.
ELECTRICAL NEURO-MUSCULAR STIMULATOR
K840895 · Richards Medical Co., Inc. · Apr 1984
NEUROMUSCULAR STIMULATOR 3105
K840467 · Medtronic Vascular · Feb 1984
NEUROMUSCLAR II
K840346 · Mentor Corp. · Feb 1984
RICH-MAR HV 20
K830055 · Rich-Mar Corp. · Mar 1983
RESPOND QUADRIFLEX #3129 SINGLE CHANNEL
K823279 · Medtronic Vascular · Nov 1982
MENTOR ACTIVATOR NEUROMUSCULAR STIMU
K820168 · Mentor Corp. · Feb 1982