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510(k) Data Aggregation
K Number
K013081Device Name
MEDSTAR 150
Manufacturer
Date Cleared
2001-11-20
(67 days)
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
MEDNET SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MEDSTAR 150 should only be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:
- symptomatic relief and management of chronic pain and/or .
- an adjunctive treatment in the management of post surgical and posttraumatic acute ● pain.
When used for neuromuscular stimulation, the standard indications for use are:
- Relaxation of muscle spasms .
- Prevention or retardation of disuse atrophy .
- Increasing local blood circulation ●
- Muscle re-education ●
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; ● and
- Maintaining or increasing rang of motion .
Device Description
The MEDSTAR 150 is a DC battery powered device that generates small pulses of electrical current. These small pulses of electrical current are delivered through lead cables to electrodes placed on the skin. These electrical pulses pass through the skin and activate underlying nerves and muscle.
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K Number
K013082Device Name
MEDSTAR 100 INTERFERENTIAL STIMLATOR
Manufacturer
Date Cleared
2001-11-16
(63 days)
Product Code
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
MEDNET SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MEDSTAR 100 Interferential Stimulator should only be used under the supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:
- symptomatic relief and management of chronic pain and/or .
- an adjunctive treatment in the management of post surgical and posttraumatic acute . pain.
Device Description
The MEDSTAR 100 is a DC battery powered device that generates small pulses of electric current. These small pulses of electrical current are delivered through leads cables to electrodes placed on the skin. These electrical pulses pass through the skin and activate underlying nerves.
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