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Date Cleared

2015-10-22

(104 days)

Product Code

Regulation Number

Intended Use

The P.R.O. CG® Manual Wheelchair is intended to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 250lbs.

Device Description

This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to Market the P.R.O. CG® Manual Wheelchair. The P.R.O. CG® Manual Wheelchair is a rigid, non-folding, manually operated, center of gravity shifting (CG) tilt-in-space wheelchair. The design incorporates a fixed width base frame that is connected to a width and depth adjustable seat frame with struts connected to tilt arcs. This design allows the seat frame to change its position using a CG shifting tilt motion. The shift moves to reposition the seat frame angle from 0° to 50° in a smooth, downward, forward, and backward motion with little change in the overall center of gravity of the frame and the occupant. The device is not marketed with upholstery in the standard or optional configurations. The subject device intended use is to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 2501bs.

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K Number

K080270

Device Name

MANUAL RIGID MOBILITY WHEELCHAIR

Manufacturer

Date Cleared

2008-04-16

(75 days)

Product Code

Regulation Number

Intended Use

This wheelchair is designed as a transport base for pediatric and adult clients.

Device Description

Not Found

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K Number

K060926

Device Name

TRIPOD

Manufacturer

Date Cleared

2006-05-19

(45 days)

Product Code

Regulation Number

Intended Use

This wheelchair is designed as a transport base for pediatric and adult clients. This device will not diagnose, treat, prevent, oure or pollarity and autor chems. I hus devi users users.

Device Description

Not Found

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K Number

K040622

Device Name

FREEDOM HP

Manufacturer

Date Cleared

2004-04-16

(38 days)

Product Code

Regulation Number

Intended Use

Device Description

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K Number

K023574

Device Name

GIZMO

Manufacturer

Date Cleared

2002-12-04

(41 days)

Product Code

Regulation Number

Intended Use

This wheelchair is designed as a transport base for pediatric clients. This device will not diagnose, treat prevent, cure or mitigate any of the population of its' intended users.

Device Description

Not Found

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K Number

K993640

Device Name

SPECTRUM LIBRE WHEELCHAIR

Manufacturer

Date Cleared

1999-11-16

(19 days)

Product Code

Regulation Number

Intended Use

Folding Mobility Wheelchair. This wheelchair is designed as a transport base for pediatric clients. This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users.

Device Description

Folding Mobility Wheelchair

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K Number

K983859

Device Name

SPECTRUM SMALL FRY

Manufacturer

Date Cleared

1998-11-25

(30 days)

Product Code

Regulation Number

Intended Use

This wheelchair is designed as a transport base for ... . . pediatric clients. This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users.

Device Description

Spectrym Small Fry Manual Folding Mobility Wheelchair

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K Number

K983763

Device Name

SPECTRUM SPIRIT

Manufacturer

Date Cleared

1998-11-23

(28 days)

Product Code

Regulation Number