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FDA 510(k)

Ceragem Automatic Thermal Massager (CGM-MB-1902)

K-Number: K243355 · 2024-11-27

Decision Date2024-11-27
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Ceragem Automatic Thermal Massager (CGM-MB-1902) is the device name listed in this FDA 510(k) record. The listed applicant is Ceragem Co., Ltd.. It received FDA 510(k) clearance on 2024-11-27 under 510(k) 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. The listed applicant is Ceragem Co., Ltd.. The 510(k) number is K243355.

When did Ceragem Automatic Thermal Massager (CGM-MB-1902) receive FDA 510(k) clearance?

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

Who is the listed applicant for Ceragem Automatic Thermal Massager (CGM-MB-1902)?

The FDA 510(k) record lists Ceragem Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Ceragem Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: JFB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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