Cleared Special

K022776 - NESS SYSTEM

K022776 is an FDA 510(k) clearance for NESS SYSTEM, manufactured by Ness-Neuromuscular Electrical Stimulation Systems. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Special 510(k) pathway after a 21-day FDA review.

K022776 · Ness-Neuromuscular Electrical Stimulation Systems · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
21d
Days
Class 2
Risk

K022776 is an FDA 510(k) clearance for the NESS SYSTEM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Ness-Neuromuscular Electrical Stimulation Systems (Washington, US). The FDA issued a Cleared decision on September 11, 2002 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K022776

510(k) Number K022776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2002
Decision Date September 11, 2002
Days to Decision 21 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 116d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 398
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K022776.
ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M
K020130 · Rolor Electronics Corp. · Dec 2002
DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS
K020750 · Everyway Medical Instruments Co.,Ltd · Oct 2002
EMS 400
K022493 · Body Clock Health Care, Ltd. · Oct 2002
P4 PHYSIO
K022175 · Valmed Corp. · Sep 2002
CLASSIC NMS
K021905 · Care Rehab, Inc. · Sep 2002
HMS-DHR-3 NEUROMUSCULAR STIMULATOR
K021472 · Home Medical Services · Aug 2002
K022776 · NESS SYSTEM
Download PDF FDA Summary Ness-Neuromuscular El…