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FDA 510(k)

CERAGEM RH1 AUTOMATIC THERMAL MASSAGER

K-Number: K062476 · 2006-10-31

ApplicantCeragem International, Inc.
Decision Date2006-10-31
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CERAGEM RH1 AUTOMATIC THERMAL MASSAGER is the device name listed in this FDA 510(k) record. The listed applicant is Ceragem International, Inc.. It received FDA 510(k) clearance on 2006-10-31 under 510(k) number K062476. 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 RH1 AUTOMATIC THERMAL MASSAGER?

CERAGEM RH1 AUTOMATIC THERMAL MASSAGER is a medical device that received FDA 510(k) clearance on 2006-10-31. The listed applicant is Ceragem International, Inc.. The 510(k) number is K062476.

When did CERAGEM RH1 AUTOMATIC THERMAL MASSAGER receive FDA 510(k) clearance?

CERAGEM RH1 AUTOMATIC THERMAL MASSAGER received FDA 510(k) clearance on 2006-10-31, under 510(k) number K062476.

Who is the listed applicant for CERAGEM RH1 AUTOMATIC THERMAL MASSAGER?

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

What is the FDA product code for CERAGEM RH1 AUTOMATIC THERMAL MASSAGER?

The FDA product code for CERAGEM RH1 AUTOMATIC THERMAL MASSAGER is JFB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ceragem International, Inc. 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.

K111128LABONACHECK A1C

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.

K250266Ceragem Automatic Thermal Massager (CGM MB-2401)Ceragem Co., Ltd.K241193AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)Marzzan Lucas JorgeK243644Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)Ceragem Co., Ltd.K243355Ceragem Automatic Thermal Massager (CGM-MB-1902)Ceragem Co., Ltd.K240168N7-SNuga Medical Co., Ltd.K220572Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd.

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.

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