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Found 4 results
510(k) Data Aggregation
K Number
K020130Device Name
ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M
Manufacturer
ROLOR ELECTRONICS CORP.
Date Cleared
2002-12-02
(321 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
ROLOR ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Specific indications: used to apply an electrical current to electrodes on a patient's skin to function as: Relaxation of muscle spasms. Prevention or retardation of disuse atrophy Increasing local blood circulation. Maintaining or increasing range of motion.
Device Description
ROLOR POWERED MUSLCE STIMULATOR GP-8016M
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K Number
K021430Device Name
SANIDAD TENS-DUO MODE GP8016N
Manufacturer
ROLOR ELECTRONICS CORP.
Date Cleared
2002-12-02
(213 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
ROLOR ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Specific indications: it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems. Clinical settings: should be used under the instruction or prescription by qualified health professionals prior to the applications of the device at home or hospital facilities.
Device Description
Sanidad TENS-Duo Mode GP8016N
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K Number
K020464Device Name
SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646
Manufacturer
ROLOR ELECTRONICS CORP.
Date Cleared
2002-09-17
(217 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
ROLOR ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.
Device Description
Sanidad Far-Infrared Mini Lamp, FI-3646
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K Number
K020462Device Name
SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018
Manufacturer
ROLOR ELECTRONICS CORP.
Date Cleared
2002-09-16
(216 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
ROLOR ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.
Device Description
Sanidad Thermal Far-Infrared Wave Lamp, AP-2018
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