Cleared Traditional

K841647 - NEUROMEDICS ULTRASTIM 650-01

K841647 is an FDA 510(k) clearance for NEUROMEDICS ULTRASTIM 650-01, manufactured by Intermedics, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K841647 · Intermedics, Inc. · Physical Medicine device
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Jul 1984
Decision
74d
Days
Class 2
Risk

K841647 is an FDA 510(k) clearance for the NEUROMEDICS ULTRASTIM 650-01. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 3, 1984 after a review of 74 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K841647

510(k) Number K841647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1984
Decision Date July 03, 1984
Days to Decision 74 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
41d faster than avg
Panel avg: 115d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

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 166
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K841647.
SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR
K850013 · Mettler Electronics Corp. · Apr 1985
EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE
K844617 · Excel Tech. , Ltd. · Mar 1985
THE PROBE 100
K844466 · Rich-Mar Corp. · Feb 1985
EMPI MODEL 712, LOGIX, NMS
K841382 · Empi · May 1984
ELECTRICAL NEURO-MUSCULAR STIMULATOR
K840895 · Richards Medical Co., Inc. · Apr 1984
NEUROMUSCULAR STIMULATOR 3105
K840467 · Medtronic Vascular · Feb 1984