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)

THERMOFONTE AIR MESSAGE BATH

K-Number: K821809 · 1982-07-23

ApplicantGreenfields
Decision Date1982-07-23
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERMOFONTE AIR MESSAGE BATH is the device name listed in this FDA 510(k) record. The listed applicant is Greenfields. It received FDA 510(k) clearance on 1982-07-23 under 510(k) number K821809. The device is classified under product code ILJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOFONTE AIR MESSAGE BATH?

THERMOFONTE AIR MESSAGE BATH is a medical device that received FDA 510(k) clearance on 1982-07-23. The listed applicant is Greenfields. The 510(k) number is K821809.

When did THERMOFONTE AIR MESSAGE BATH receive FDA 510(k) clearance?

THERMOFONTE AIR MESSAGE BATH received FDA 510(k) clearance on 1982-07-23, under 510(k) number K821809.

Who is the listed applicant for THERMOFONTE AIR MESSAGE BATH?

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

What is the FDA product code for THERMOFONTE AIR MESSAGE BATH?

The FDA product code for THERMOFONTE AIR MESSAGE BATH is ILJ.

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: ILJ)

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.

K110994PARKER 500Arjohuntleigh, Inc.K082951IMMERSION HYDROBATHArjo Hospital Equipment ABK052479MBATH 1000 (60)Enneking Medical, Inc.K040772PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEMPenner Manufacturing, Inc.K012061SUPERIOR BATH, MODEL 6300Penner Manufacturing, Inc.K012057CASCADE BATH, MODEL 6900Penner Manufacturing, 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.

↑