Smart Rail 1 Pack - The Smart-Rail is a bed rail with 2 positions: - Healthcraft Products Inc.

Duns Number:252468293

Device Description: The Smart-Rail is a bed rail with 2 positions: closed and opened. In the closed position, The Smart-Rail is a bed rail with 2 positions: closed and opened. In the closed position, the rail is latched to the support frame to assist with in-bed positioning. In the opened position, the rail is unlatched from the support frame and pivoted out to the optimal location to assist with sitting and standing. The Smart-Rail is intended ONLY for moderate vertical load bearing to provide bed positioning, sitting and standing support for people with reduced mobility. The Smart-Rail is installed between the mattress and box spring, and is secured in place with a safety strap. In the closed position, the Smart-Rail is height adjustable to accommodate the thickness of the mattress. In the opened position, the Smart-Rail is height adjustable to accommodate the height of the user. The maximum user weight for this product is 300lbs / 136kgs. Product is not intended to support full body weight.

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More Product Details

Catalog Number

01984

Brand Name

Smart Rail 1 Pack

Version/Model Number

SRS-S-1PK

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IKX

Product Code Name

Aid, Transfer

Device Record Status

Public Device Record Key

42abd9da-f5ae-4898-9a51-afbb28afa0fb

Public Version Date

September 02, 2021

Public Version Number

1

DI Record Publish Date

August 25, 2021

Additional Identifiers

Package DI Number

10689281019849

Quantity per Package

4

Contains DI Package

00689281019842

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"HEALTHCRAFT PRODUCTS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 298