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510(k) Data Aggregation
K Number
K160246Device Name
SimulCare II(TM)
Manufacturer
XANACARE TECHNOLOGIES, LLC
Date Cleared
2016-10-06
(248 days)
Product Code
GZJ, ILY, ISA
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
XANACARE TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SimulCare II™ is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic pain.
Device Description
The SimulCare II Multi-function Therapeutic Device is modified from the SimulCare and ComboCare 2000 devices previously cleared under 510(k)s K083202 & K081141 and includes improved interface features, EMI filters, additional audible alarm and battery monitoring circuit drain prevention.
Portable, lightweight, rechargeable unit consisting of a hand-held controller with digital control of stimulation parameters and an attached flexible pad that produces battery-charged therapy consisting of red light emitting diodes, infrared light emitting diodes, micro current, macro current (E-stim), permanent magnets and vibratory massage.
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K Number
K083202Device Name
COMBOCARE 2000
Manufacturer
XANACARE TECHNOLOGIES, LLC
Date Cleared
2008-12-15
(46 days)
Product Code
GZJ, ILY, ISA
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
XANACARE TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.
Device Description
This device, modified from the ComboCare 2000 device previously cleared under 510(k) K081141, includes the addition of permanent magnets to the flexible pads to create a static magnetic field and increased Infrared light strength for therapeutic heating.
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K Number
K081141Device Name
COMBOCARE 2000
Manufacturer
XANACARE TECHNOLOGIES, LLC
Date Cleared
2008-08-29
(129 days)
Product Code
GZJ, ISA, NHN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
XANACARE TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting relaxation of muscle tissue, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.
Device Description
The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting relaxation of muscle tissue, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.
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