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)

REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600

K-Number: K013328 · 2001-12-03

ApplicantRemington Products Company, LLC
Decision Date2001-12-03
Product CodeIMC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 is the device name listed in this FDA 510(k) record. The listed applicant is Remington Products Company, LLC. It received FDA 510(k) clearance on 2001-12-03 under 510(k) number K013328. 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 REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600?

REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 is a medical device that received FDA 510(k) clearance on 2001-12-03. The listed applicant is Remington Products Company, LLC. The 510(k) number is K013328.

When did REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 receive FDA 510(k) clearance?

REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 received FDA 510(k) clearance on 2001-12-03, under 510(k) number K013328.

Who is the listed applicant for REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600?

The FDA 510(k) record lists Remington Products Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600?

The FDA product code for REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 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

Other records listing Remington Products Company, LLC 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.

K895410REMINGTON TANFASTIC HANDHELD TANNING WANDK895409REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER

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.K001860PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRAHomedics, Inc.K991427PARAMED PARAFFIN WARMERDivi Intl. Co.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.

↑