P.T. Rail™, Hinged, (Powder Coat White +3 more)

FDA UDI

Class I (US FDA UDI)

by Healthcraft Products Inc.

Identity

Trade Name: P.T. Rail™, Hinged, (Powder Coat White, 36"/91cm, Left) FDA UDI
Generic Name: Bath hand rail FDA UDI
Device Name: 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. Note: Product is not intended to support full body weight. FDA UDI
Model / Reference: PT-WR36L-PCW FDA UDI
Description: 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. Note: Product is not intended to support full body weight. FDA UDI

Identifiers

Catalog Number: 03522 FDA UDI
Primary DI / UDI-DI: 00689281035224 FDA UDI
FDA Product Code: IKX FDA UDI
GMDN Term: Bath hand rail FDA UDI
Models / Variants: Powder Coat White FDA UDI
36" FDA UDI
91cm FDA UDI
Left FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

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Expiration Date

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Manufacturing Date

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Category: Bath hand rail

P.T. Rail™, Hinged, (Powder Coat White +3 more) by Healthcraft Products Inc. — Class I — FDA UDI — listed in FDA GUDID — 4 models — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Healthcraft Products Inc.

Sources (1)

FDA UDI ff32b47f-1ea5-420a-b97d-96af056a0805 34 fields · synced Jun 1, 2026