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510(k) Data Aggregation
K Number
K111128Device Name
LABONACHECK A1C
Manufacturer
CERAGEM INTERNATIONAL, INC.
Date Cleared
2012-09-13
(511 days)
Product Code
LCP
Regulation Number
864.7470Why did this record match?
Applicant Name (Manufacturer) :
CERAGEM INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LabonaCheck™ A1c is intended for the quantitative measurement of glycated hemoglobin in venous whole blood and capillary fingerstick samples. This device is intended for multiple patient, professional use. Measurement of percent glycated hemoglobin (HbA 1c) is effective in monitoring long-term glucose control in individuals with diabetes mellitus by using the LabonaCheck™ A1c. Only auto-disabling, single use lancing devices should be used with this system.
Device Description
The system consists of HbA1c Analyzer (MH 200) and HbA1c Test kit. The LabonaCheck™ AIc HbAic Analyzer measures the coloured responses of the LabonaCheck™ A1c HbA1c Test Kit by spectral reflectance.
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K Number
K062476Device Name
CERAGEM RH1 AUTOMATIC THERMAL MASSAGER
Manufacturer
CERAGEM INTERNATIONAL, INC.
Date Cleared
2006-10-31
(68 days)
Product Code
JFB
Regulation Number
890.5880Why did this record match?
Applicant Name (Manufacturer) :
CERAGEM INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the CERAGEM – RH1 Automatic Thermal Massager is to provide the user with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:
- ◊ temporary relief of minor muscle and joint pain, and stiffness
- ُ the temporary relief of minor joint pain associated with arthritis
- the temporary increase in local circulation where applied
- 0 relaxation of muscles
Device Description
The CERAGEM - RH1 Automatic Thermal Massager is an electrically powered motorized multi-functional physical therapy table. Its intended use is to provide muscle relaxation therapy by delivering heat and soothing massage. The massage function is delivered by massage rollers mounted on an independent carriage underneath a pad on the table's torso section. The heat function is delivered by two components: 1) heated jade massage rollers mounted together on the moving carriage and 2) heated Epoxy Carbon Panels. In both cases, radiant infrared heat is emitted. Together, the massage action and heated pressure points apply light pressure as well as heat to the user.
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