MODEL 1700, HYDRO PREP

K970694 · Physiometrix, Inc. · GYB · May 14, 1997 · Neurology

Device Facts

• Record ID: K970694
• Device Name: MODEL 1700, HYDRO PREP
• Applicant: Physiometrix, Inc.
• Product Code: GYB · Neurology
• Decision Date: May 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1275
• Device Class: Class 2

Intended Use

HydroPrep and NuPrep are skin preparation materials that are designed for use by EEG Technicians. Both substances are applied to the skin surface with a cotton swab in order to reduce skin impedance and increase signal quality recorded with EEG electrodes. HydroPrep is not intended for use with stimulating electrodes.

Device Story

HydroPrep is a skin preparation solution; applied to skin via cotton swab; reduces skin impedance; improves EEG signal quality. Used by EEG technicians in clinical settings. Formulation contains water, salt, preservatives, and gritty media. Not for use with stimulating electrodes.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Skin preparation solution; contains water, salt, preservatives, and gritty media. Applied topically via cotton swab.

Indications for Use

Indicated for use by EEG technicians to prepare skin surfaces for EEG electrode application to reduce impedance and improve signal quality. Not for use with stimulating electrodes.

Regulatory Classification

Identification

Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

Predicate Devices

• NuPrep (K885306)

Submission Summary (Full Text)

{0}

TOTAL P. 03
K970694
Physiometrix, Inc.
510(k), Premarket Notification
Model 1700, HydroPrep
MAY 14 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

Date: February 24, 1997

Company: Physiometrix, Inc.
Five Billerica Park
101 Billerica Avenue
N. Billerica, MA 01862

Contact: Dawn E. Frazer
Director, Regulatory Affairs & Quality Assurance
[phone]
[phone]

Subject Device: Model 1700, HydroPrep

Predicate Device: K885306, NuPrep (Weaver & Co.)

Classification: 882.1275 Electroproductive media

Description: HydroPrep is a skin preparation solution similar to NuPrep. It is different in that is has more water and more salt that the current formulation. It used the same preservatives and gritty media.

Intended Use: HydroPrep and NuPrep are skin preparation materials that are designed for use by EEG Technicians. Both substances are applied to the skin surface with a cotton swab in order to reduce skin impedance and increase signal quality recorded with EEG electrodes. HydroPrep is not intended for use with stimulating electrodes.

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