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

FDA 510(k)

CARESS MASSAGER

K-Number: K904915 · 1990-11-27

ApplicantKendex Corp.
Decision Date1990-11-27
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CARESS MASSAGER is the device name listed in this FDA 510(k) record. The listed applicant is Kendex Corp.. It received FDA 510(k) clearance on 1990-11-27 under 510(k) number K904915. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARESS MASSAGER?

CARESS MASSAGER is a medical device that received FDA 510(k) clearance on 1990-11-27. The listed applicant is Kendex Corp.. The 510(k) number is K904915.

When did CARESS MASSAGER receive FDA 510(k) clearance?

CARESS MASSAGER received FDA 510(k) clearance on 1990-11-27, under 510(k) number K904915.

Who is the listed applicant for CARESS MASSAGER?

The FDA 510(k) record lists Kendex Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARESS MASSAGER?

The FDA product code for CARESS MASSAGER is ISA.

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

Related Devices (Code: ISA)

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.

K243488VMAT PROTermosaludK240358ShockPhysio Mobile (model SW3200 Basic)Shenzhen Dongdixin Technology Co., Ltd.K221865BTL-094BTL Industries, Inc.K210166Omnispec ED1000Medispec, Ltd.K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave TrtK220538DolorClast RadialE.M.S Electro Medical Systems S.A

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.

↑