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FDA 510(k)

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

K-Number: K243644 · 2025-01-08

ApplicantCeragem Co., Ltd.
Decision Date2025-01-08
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) is a medical device manufactured by Ceragem Co., Ltd.. It received FDA 510(k) clearance on 2025-01-08 under approval number K243644. 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-2301 & CGM MB-2302)?

Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) is a medical device that received FDA 510(k) clearance on 2025-01-08. It is manufactured by Ceragem Co., Ltd.. The 510(k) number is K243644.

When was Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) approved by the FDA?

Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) received FDA 510(k) clearance on 2025-01-08, under approval number K243644.

What company makes Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)?

Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) is manufactured by Ceragem Co., Ltd..

What is the FDA product code for Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)?

The FDA product code for Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) 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 K243355Ceragem Automatic Thermal Massager (CGM-MB-1902) K250266Ceragem Automatic Thermal Massager (CGM MB-2401)

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. K243355Ceragem Automatic Thermal Massager (CGM-MB-1902)Ceragem Co., Ltd. K240168N7-SNuga Medical 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.

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