K-number	K243644
Device name	Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
Applicant	Ceragem Co., Ltd.
Product code	JFB
Device class	Class II
Decision date	Jan 8, 2025
Decision	Substantially Equivalent
Regulation	890.5880

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Ceragem Automatic Thermal Massager (Models CGM MB-2301 and CGM MB-2302) is an over-the-counter device that provides muscle relaxation therapy through heat and massage. It delivers topical infrared heat for temporary relief of minor muscle and joint pain, stiffness, arthritis-related pain, and increased local circulation. It includes an Air Cell Massager component that uses an inflatable garment to stimulate kneading and stroking of tissues.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)

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