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)

PARAMED PARAFFIN WARMER

K-Number: K991427 · 1999-08-13

ApplicantDivi Intl. Co.
Decision Date1999-08-13
Product CodeIMC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PARAMED PARAFFIN WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Divi Intl. Co.. It received FDA 510(k) clearance on 1999-08-13 under 510(k) number K991427. The device is classified under product code IMC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAMED PARAFFIN WARMER?

PARAMED PARAFFIN WARMER is a medical device that received FDA 510(k) clearance on 1999-08-13. The listed applicant is Divi Intl. Co.. The 510(k) number is K991427.

When did PARAMED PARAFFIN WARMER receive FDA 510(k) clearance?

PARAMED PARAFFIN WARMER received FDA 510(k) clearance on 1999-08-13, under 510(k) number K991427.

Who is the listed applicant for PARAMED PARAFFIN WARMER?

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

What is the FDA product code for PARAMED PARAFFIN WARMER?

The FDA product code for PARAMED PARAFFIN WARMER is IMC.

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: IMC)

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.

K093100REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)Shenzhen Comfort Technology Co., Ltd.K022626MOISTURESTAY (REVLON)Raymond Industrial, Ltd.K013707SOFTIQUE, MODEL GI 11001Global TV Concepts, Ltd.K013328REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600Remington Products Company, LLCK001860PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRAHomedics, Inc.K980718PARA-CAREChattanooga Group, 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.

↑