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)

PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA

K-Number: K001860 · 2000-08-10

ApplicantHomedics, Inc.
Decision Date2000-08-10
Product CodeIMC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA is the device name listed in this FDA 510(k) record. The listed applicant is Homedics, Inc.. It received FDA 510(k) clearance on 2000-08-10 under 510(k) number K001860. 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 PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA?

PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA is a medical device that received FDA 510(k) clearance on 2000-08-10. The listed applicant is Homedics, Inc.. The 510(k) number is K001860.

When did PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA receive FDA 510(k) clearance?

PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA received FDA 510(k) clearance on 2000-08-10, under 510(k) number K001860.

Who is the listed applicant for PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA?

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

What is the FDA product code for PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA?

The FDA product code for PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA 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 Homedics, Inc. 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.

K012914SONICWAVE SONIC PLAQUE REMOVER

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, LLCK991427PARAMED 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.

↑