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510(k) Data Aggregation
K Number
K150742Device Name
Muscle Stimulation System 110
Manufacturer
Date Cleared
2015-07-23
(122 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
NIVEUS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Niveus Medical Muscle Stimulation System 110 is indicated for:
- 1) Maintaining or increasing range of motion of the knee joint
- 2) Prevention or retardation of disuse atrophy in the quadriceps
- 3) Muscle re-education of the quadriceps
- 4) Relaxation of muscle spasms
- 5) Increasing local blood circulation
Device Description
The Muscle Stimulation System 110 is a portable, externally-powered device which provides electrical stimulation to the quadriceps using constant current pulses. Pulses are delivered via six independently controlled stimulation channels (3 per leg) and are provided to the patient via electrodes integrated into soft Stimulation Array Pads. An Interconnect Cable allows for communication between the System Controller and Stimulation Array Pads.
The major components of the system consist of a Controller, an Interconnect Cable, a pair of disposable Stimulation Array Pads configured for application to the quadriceps of a patient, a Power Cord, and Instructions for Use. An optional accessory to the system is the Niveus Medical StayCool FlexPaks.
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K Number
K123642Device Name
MUSCLE STIMULATION SYSTEM
Manufacturer
Date Cleared
2013-03-29
(123 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
NIVEUS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Muscle Stimulation System 110 is indicated for:
- Maintaining or increasing range of motion of the knee joint
- Prevention or retardation of disuse atrophy in the quadriceps
- Muscle re-education of the quadriceps
- Relaxation of muscle spasms
- Increasing local blood circulation
Device Description
The Muscle Stimulation System 110 is a portable, externallypowered device which provides electrical stimulation to the quadriceps using constant current pulses. The device is a Powered Muscle Stimulator per 21 CFR § 890.5850 (Product Code: IPF). Pulses are delivered via six independently controlled stimulation channels (3 per leg) and are provided to the patient via electrodes integrated into disposable Stimulation Array Pads. An Interconnect Cable allows for communication between the System Controller and Stimulation Array Pads.
The major components of the system consist of a Controller, an Interconnect Cable, a pair of disposable Stimulation Array Pads configured for application to the quadriceps of a patient, a Power Cord, and instructions for use.
Ask a Question
Ask a specific question about this device
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