Search Results
Found 1 results
510(k) Data Aggregation
K Number
K140592Device Name
CERAGEM AUTOMATIC THERMAL MASSAGER
Manufacturer
Ceragem International Inc.
Date Cleared
2014-12-17
(285 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® Thermal Massager Model CGM-MB-1101 Automatic Thermal Massager is to provide 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 stiffness
- Temporary relief of minor joint pain associated with arthritis
- Temporary increase in local circulation where applied
- Relaxation of muscles
Device Description
This device is comprised of the main body and optional components. The main body components are the main mat which includes the internal projector and the up/down movement motor, and the lower mat. The optional components are the external projectors (3-sphere). This device is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle and joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors.
Ask a Question
Page 1 of 1