3050 SPORT-NEB

K964078 · Medical Industries America, Inc. · CAF · Jan 10, 1997 · Anesthesiology

Device Facts

• Record ID: K964078
• Device Name: 3050 SPORT-NEB
• Applicant: Medical Industries America, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Jan 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The model 3050 "Sport-Neb" is a small air compressor designed to provide sufficient air pressure and flow to power a hand held nebulizer such as the Salter #8900.

Device Story

Small, lightweight air compressor; provides air pressure/flow to power hand-held nebulizers (e.g., Salter #8900). Device comprises motor compressor assembly, wiring, switch, power cord, and ABS plastic housing. Used in home or clinical settings; operated by patients or caregivers. Provides pneumatic power to nebulizer; enables aerosol medication delivery. Portable design; smaller form factor than predicate AEROMAX.

Clinical Evidence

Bench testing only; no clinical data provided. Device equivalence established through design comparison and functional similarity to predicate.

Technological Characteristics

ABS plastic housing; dimensions 7.5" x 7.5" x 4.5"; AC-powered motor compressor assembly; pneumatic output via air outlet barb; manual switch operation.

Indications for Use

Indicated for patients requiring aerosolized medication delivery via a hand-held nebulizer powered by an external air compressor.

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Predicate Devices

• AEROMAX (Model 3002)

Reference Devices

• Salter #8900 (nebulizer)

Submission Summary (Full Text)

{0}

MEDICAL INDUSTRIES AMERICA INC.

2879 R AVENUE
ADEL, IOWA
U.S.A. 50003-8055

TEL. [phone]
1-800-759-3038
FAX [phone]

K964078
JAN. 10, 1997

ENCLOSURE 'B'

EXECUTIVE SUMMARY OF THE MODEL 3050 "SPORT-NEB"

The model 3050 "Sport-Neb" is a small air compressor designed to provide sufficient air pressure and flow to power a hand held nebulizer such as the Salter #8900.

Nebulizer compressors are very basic devices comprising of a motor compressor assembly, wiring, switch, power cord and case. Nebulizer compressors have been on the market for many years. "Medical Industries America, Inc." is currently marketing two other nebulizer compressors - the "Aerosol Two" and the "AEROMAX". The "Sport-Neb" is virtually the same as the "AEROMAX" with the exception of the case which is smaller and more portable.

## DEVICE DESCRIPTION:

The Model 3050 "sport-Neb" is a small, lightweight, nebulizer compressor. It measures 7 1/2" X 7 1/2" X 4 1/2". The housing is grey in color and moulded from ABS plastic. External components include a switch, filter housing, AC cord and the air outlet barb. An optional carry bag will be offered to store the patients hand held nebulizer.

The handle is built into the housing

The operating components are located internally. The compressor, some minor wiring and the exhaust/intake plumbing are located inside.

## MODIFICATIONS:

At this time, there are no intentions to modify the device.

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{1}

MEDICAL INDUSTRIES AMERICA INC.
2879 R AVENUE
ADEL, IOWA
U.S.A. 50003-8055
TEL. [phone]
1-800-759-3038
FAX [phone]

ENCLOSURE 'B'

EXECUTIVE SUMMARY OF THE MODEL 3050 "SPORT-NEB" COMPRESSOR (CONTINUED)

DESCRIPTION OF THE MODEL 3002 "AEROMAX" (PREDICATE DEVICE)

The Model 3002 "AEROMAX" manufactured by "Medical Industries America, Inc. is also a small, lightweight nebulizer compressor. It measures approximately 12 X 8 1/2 X 4 1/2. It is grey in color.

In the front of the device is the lid. Under the lid are the following components - switch, AC cord, filter housing and air outlet barb.

The "AEROMAX" has the operating components located internally also. The compressor, the intake/exhaust plumbing and the wiring system are located here.

INTENDED USE:

The Model 3002 "AEROMAX" has the same intended use as the Model 3050.

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