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)

RHYTHM WHEEL

K-Number: K813497 · 1982-05-03

ApplicantTropical Enterprises, Inc.
Decision Date1982-05-03
Product CodeLHD
DecisionSubstantially Equivalent

Device Summary

RHYTHM WHEEL is the device name listed in this FDA 510(k) record. The listed applicant is Tropical Enterprises, Inc.. It received FDA 510(k) clearance on 1982-05-03 under 510(k) number K813497. The device is classified under product code LHD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHYTHM WHEEL?

RHYTHM WHEEL is a medical device that received FDA 510(k) clearance on 1982-05-03. The listed applicant is Tropical Enterprises, Inc.. The 510(k) number is K813497.

When did RHYTHM WHEEL receive FDA 510(k) clearance?

RHYTHM WHEEL received FDA 510(k) clearance on 1982-05-03, under 510(k) number K813497.

Who is the listed applicant for RHYTHM WHEEL?

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

What is the FDA product code for RHYTHM WHEEL?

The FDA product code for RHYTHM WHEEL is LHD.

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: LHD)

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.

K200163Ava Fertility TrackerAva AGK122337OVUSENSEFertility Focus, Ltd.K102499DUOFERTILITYCambridge Temperature Concepts , Ltd.K050094LADY COMP USALady Comp USAK030961MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921Microlife Corp.K021978PETIT SOPHIANishitomo Co., Inc.

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.

↑