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510(k) Data Aggregation
K Number
K030403Device Name
CEFAR REHAB 2 AND REHAB 2 PRO
Manufacturer
CEFAR MEDICAL AB
Date Cleared
2003-07-17
(161 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
CEFAR MEDICAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are symmetrical biphasic neuromuscular electronic stimulators indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. Intended uses include:
- 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
- Maintaining or increasing range of motion
Device Description
The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are battery powered handheld Neuro-Muscular Electrical Stimulation (NMES) devices only to be used under medical supervision for adjunctive therapy of medical diseases and conditions. The devices operate with two channels and 22 preset stimulation programs. On the CEFAR REHAB 2 PRO the user also can set parameters to create user defined stimulation programs.
Program information and amplitude is displayed on a LCD. The user can set the amplitude in the range 0-100 mA for all programs.
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K Number
K020803Device Name
CEFAR MEDICAL AB CEFAR PRIMO
Manufacturer
CEFAR MEDICAL AB
Date Cleared
2002-06-10
(90 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
CEFAR MEDICAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS stimulation is used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.
Device Description
The CEFAR Primo is a handheld battery powered TENS device with two channels and nine preset stimulation programs. The two channels are separated and it is possible to stimulate with two different stimulation programs simultaneously, one on each channel. Program information and electrical current amplitude is displayed on a LCD. The user can set the amplitude in the range 0-60 mA for all programs.
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