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K Number
K003916
Device Name
DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM
Manufacturer
SCANDIA MANUFACTURING LTD.
Date Cleared
2002-04-15

(482 days)

Product Code
IMB
Regulation Number
890.5250
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
    1. To temporarily increase local blood circulation.
    1. To temporarily reduce minor muscular pain.
    1. To help induce relaxation of muscles.
    1. To treat arthritis and fibrosis.
    1. To provide topical heating.
Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot answer the request as the document does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for the DermaMED System, which states that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use. It does not include details on specific device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

§ 890.5250 Moist steam cabinet.

(a)
Identification. A moist steam cabinet is a device intended for medical purposes that delivers a flow of heated, moisturized air to a patient in an enclosed unit. It is used to treat arthritis and fibrosis (a formation of fibrosis tissue) and to increase local blood flow.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.