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K Number
K111767
Device Name
NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
Manufacturer
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
Date Cleared
2011-09-15

(84 days)

Product Code
GZI
Regulation Number
882.5810
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The NESS H200® Wireless Hand Rehabilitation System is an electrical stimulation device indicated for the following uses:

Functional Electrical Stimulation (FES):

  • Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury
  • NeuroMuscular Electrical Stimulation (NMES):
  • -Maintenance and/or increase of range of motion
  • -Prevention and/or retardation of disuse atrophy
  • Increase of local blood circulation -
  • Reduction of muscle spasm -
  • -Muscle re-education
Device Description

The NESS H200® Wireless Hand Rehabilitation System is an electrical stimulation device.

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the NESS H200 Wireless Hand Rehabilitation System. This document grants market clearance based on substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance.

The document discusses the regulatory classification, indications for use, and general controls for the device. It does not include:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes, data provenance, or details about test and training sets.
  • Information about expert involvement for ground truth establishment or adjudication methods.
  • Details on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
  • The type of ground truth used for any performance evaluation.
  • Sample sizes or ground truth establishment for a training set.

Therefore, I cannot extract the requested information from the provided text.

§ 882.5810 External functional neuromuscular stimulator.

(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).