Cleared Traditional

MEDCOLATOR MODEL HVX (K844580) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844580 · Medco Products, Co., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
94d
Days
Class 2
Risk

K844580 is an FDA 510(k) clearance for the MEDCOLATOR MODEL HVX. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Medco Products, Co., Inc. (Tinton Falls, US). The FDA issued a Cleared decision on February 25, 1985 after a review of 94 days - within the typical 510(k) review window.

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: 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 Medco Products, Co., Inc. devices

Submission Details

510(k) Number K844580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1984
Decision Date February 25, 1985
Days to Decision 94 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
21d faster than avg
Panel avg: 115d · This submission: 94d
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 546
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K844580.
High Tone Power therapy (HiToP) (Model: HiToP PNP)
K252816 · Mohammadali Nezakati · Jun 2026
StimelMD (SSMD) system
K260142 · Motion Informatics ltd. · May 2026
Compact II
K251083 · Enraf-Nonius, B.V. · Sep 2025
EVE Synergy (EVE-20M)
K241433 · Weero Co., Ltd. · Jun 2025
TrainFES Advance
K241488 · Trainfes · Feb 2025
Quantum Mitohormesis (QMT) (M2101)
K240348 · Quantumtx Pte. , Ltd. · Dec 2024