Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ceragem Automatic Thermal Massager (CGM-MB-1902)

K-Number: K243355 · 2024-11-27

ApplicantCeragem Co., Ltd.
Decision Date2024-11-27
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Ceragem Automatic Thermal Massager (CGM-MB-1902) is a medical device manufactured by Ceragem Co., Ltd.. It received FDA 510(k) clearance on 2024-11-27 under approval number K243355. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ceragem Automatic Thermal Massager (CGM-MB-1902)?

Ceragem Automatic Thermal Massager (CGM-MB-1902) is a medical device that received FDA 510(k) clearance on 2024-11-27. It is manufactured by Ceragem Co., Ltd.. The 510(k) number is K243355.

When was Ceragem Automatic Thermal Massager (CGM-MB-1902) approved by the FDA?

Ceragem Automatic Thermal Massager (CGM-MB-1902) received FDA 510(k) clearance on 2024-11-27, under approval number K243355.

What company makes Ceragem Automatic Thermal Massager (CGM-MB-1902)?

Ceragem Automatic Thermal Massager (CGM-MB-1902) is manufactured by Ceragem Co., Ltd..

What is the FDA product code for Ceragem Automatic Thermal Massager (CGM-MB-1902)?

The FDA product code for Ceragem Automatic Thermal Massager (CGM-MB-1902) is JFB.

Other Devices by Ceragem Co., Ltd.

K202937Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 K202113Ceragem Automatic Thermal Massager, Model CGM-MB-1901 K220572Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 K250266Ceragem Automatic Thermal Massager (CGM MB-2401) K243644Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)

Related Devices (Code: JFB)

K153054N5-1Nuga Medical Co., Ltd. K202937Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702Ceragem Co., Ltd. K202113Ceragem Automatic Thermal Massager, Model CGM-MB-1901Ceragem Co., Ltd. K220572Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd. K240168N7-SNuga Medical Co., Ltd. K250266Ceragem Automatic Thermal Massager (CGM MB-2401)Ceragem Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑