Healthcraft Products Inc.

Address:2790 FENTON RD.,OTTAWA Ontario,CA

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Device Description : The P.T.Rail is a high quality, commercial grade, fold down rail for use beside The P.T.Rail is a high quality, commercial grade, fold down rail for use beside a toilet. The P.T.Rail features an offset handle to help reduce strain when gripping the lower rail. The P.T.Rail is intended for moderate vertical and horizontal load bearing to provide sitting and standing toilet support for people with reduced mobility. The P.T.Rail is intended to bear weight ONLY when the handle is in the down position; the handle is not intended to bear weight in any other position. The P.T.Rail handle is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The P.T.Rail is installed with appropriate fasteners to a tructural wall. The maximum user weight for this product is 400lbs / 181kgs

Device Class : 1

Duns Number: 252468293

Premarket Exempt : Yes

Product Code : IKX

Prescription Use : No

Device Count : 1

Device Description : The P.T.Rail is a high quality, commercial grade, fold down rail for use beside The P.T.Rail is a high quality, commercial grade, fold down rail for use beside a toilet. The P.T.Rail features an offset handle to help reduce strain when gripping the lower rail. The P.T.Rail is intended for moderate vertical and horizontal load bearing to provide sitting and standing toilet support for people with reduced mobility. The P.T.Rail is intended to bear weight ONLY when the handle is in the down position; the handle is not intended to bear weight in any other position. The P.T.Rail handle is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The P.T.Rail is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 400lbs / 181kgs.

Device Class : 1

Duns Number: 252468293

Premarket Exempt : Yes

Product Code : IKX

Prescription Use : No

Device Count : 1

Device Description : The P.T.Rail is a high quality, commercial grade, fold down rail for use beside The P.T.Rail is a high quality, commercial grade, fold down rail for use beside a toilet. The P.T.Rail features an offset handle to help reduce strain when gripping the lower rail. The P.T.Rail is intended for moderate vertical and horizontal load bearing to provide sitting and standing toilet support for people with reduced mobility. The P.T.Rail is intended to bear weight ONLY when the handle is in the down position; the handle is not intended to bear weight in any other position. The P.T.Rail handle is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The P.T.Rail is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 400lbs / 181kgs.

Device Class : 1

Duns Number: 252468293

Premarket Exempt : Yes

Product Code : IKX

Prescription Use : No

Device Count : 1

Device Description : The P.T.Rail Floor Mast is a high quality, commercial grade, floor mounted post The P.T.Rail Floor Mast is a high quality, commercial grade, floor mounted post that supports a P.T.Rail.The Floor Mast is a floor mounted structural member intended to provide a mounting surface for a P.T.Rail (in cases where wall fastening is not an option). The Floor Mast is installed with appropriate fasteners to a structural floor. The P.T.Rail is height adjustable on the Floor Mast. Must use supplied fasteners to install P.T.Rail to Floor Mast. The maximum user weight for this product is 400lbs / 181kgs

Device Class : 1

Duns Number: 252468293

Premarket Exempt : Yes

Product Code : IKX

Prescription Use : No

Device Count : 1

Device Description : The P.T.Rail Floor Mast is a high quality, commercial grade, floor mounted post The P.T.Rail Floor Mast is a high quality, commercial grade, floor mounted post that supports a P.T.Rail.The Floor Mast is a floor mounted structural member intended to provide a mounting surface for a P.T.Rail (in cases where wall fastening is not an option). The Floor Mast is installed with appropriate fasteners to a structural floor. The P.T.Rail is height adjustable on the Floor Mast. Must use supplied fasteners to install P.T.Rail to Floor Mast. The maximum user weight for this product is 400lbs / 181kgs.

Device Class : 1

Duns Number: 252468293

Premarket Exempt : Yes

Product Code : IKX

Prescription Use : No

Device Count : 1

Device Description : The Angled Ceiling Plate is a high quality, commercial grade installation access The Angled Ceiling Plate is a high quality, commercial grade installation accessory to be used with the SuperPole.The Angled Ceiling Plate is intended to permit the SuperPole to be installed in areas where the ceiling is vaulted or angled.The Angled Ceiling Plate attaches to the top of the pole and is adjustable in angle from 0-45°. The Angled Ceiling Plate must be secured to ceiling joists with appropriate fasteners.The Angled Ceiling Plate is only to be used with HealthCraft’s SuperPole System.Floor To Ceiling Height = 93-99" / 2362-2515mm Max User Weight = 300lbs / 136kgs

Device Class : 1

Duns Number: 252468293

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Device Description : The SuperBar is a high quality, commercial grade pivoting and locking horizontal The SuperBar is a high quality, commercial grade pivoting and locking horizontal bar that connects to the SuperPole (floor to ceiling safety pole). The horizontal bar can be lifted, pivoted and lowered to the next locking position around the SuperPole. The SuperBar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The SuperBar is installed onto the SuperPole by securing a castellated collar to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the collar in place, and the spring ring is used to prevent the set screws from back-threading. The castellated collar has 8 grooves (every 45 degrees) to provide a mechanism strong enough for the SuperBar to support the user. It is important to set proper height and orientation of the SuperBar to optimize the user’s range of motion. The SuperBar is made from robust materials and is capable of supporting vigorous forces during proper / normal usage. The structural components of the pole are made from metal. The plastic bushings of the SuperBar allow the horizontal bar to be rotated without marking or damaging the pole.

Device Class : 1

Duns Number: 252468293

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Device Description : The SuperBar is a high quality, commercial grade pivoting and locking horizontal The SuperBar is a high quality, commercial grade pivoting and locking horizontal bar that connects to the SuperPole (floor to ceiling safety pole). The horizontal bar can be lifted, pivoted and lowered to the next locking position around the SuperPole. The SuperBar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The SuperBar is installed onto the SuperPole by securing a castellated collar to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the collar in place, and the spring ring is used to prevent the set screws from back-threading. The castellated collar has 8 grooves (every 45 degrees) to provide a mechanism strong enough for the SuperBar to support the user. It is important to set proper height and orientation of the SuperBar to optimize the user’s range of motion. The top plate and base plate can be easily separated from the SuperPole by use of multiple use fasteners (clevis and cotter pin). The top plate can be secured to the structural ceiling joist with wood screws: - if regular inspection (and if necessary, tightening) cannot be done - if pole is subjected to aggressive usage

Device Class : 1

Duns Number: 252468293

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Device Description : The SuperBar is a high quality, commercial grade pivoting and locking horizontal The SuperBar is a high quality, commercial grade pivoting and locking horizontal bar that connects to the SuperPole (floor to ceiling safety pole). The horizontal bar can be lifted, pivoted and lowered to the next locking position around the SuperPole. The SuperBar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The SuperBar is installed onto the SuperPole by securing a castellated collar to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the collar in place, and the spring ring is used to prevent the set screws from back-threading. The castellated collar has 8 grooves (every 45 degrees) to provide a mechanism strong enough for the SuperBar to support the user. It is important to set proper height and orientation of the SuperBar to optimize the user’s range of motion. Floor To Ceiling Height 93-99" / 2362-2515mm Max User Weight 450lbs / 205kgs

Device Class : 1

Duns Number: 252468293

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Device Description : The SuperBar is a high quality, commercial grade pivoting and locking horizontal The SuperBar is a high quality, commercial grade pivoting and locking horizontal bar that connects to the SuperPole (floor to ceiling safety pole). The horizontal bar can be lifted, pivoted and lowered to the next locking position around the SuperPole. The SuperBar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The SuperBar is installed onto the SuperPole by securing a castellated collar to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the collar in place, and the spring ring is used to prevent the set screws from back-threading. The castellated collar has 8 grooves (every 45 degrees) to provide a mechanism strong enough for the SuperBar to support the user. It is important to set proper height and orientation of the SuperBar to optimize the user’s range of motion. Floor To Ceiling Height 93-99" / 2362-2515mm Max User Weight450lbs / 205kgs

Device Class : 1

Duns Number: 252468293

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1