THE FREEDOM BED

K954671 · Probed Medical Technologies, Inc. · IKZ · Apr 1, 1996 · Physical Medicine

Device Facts

• Record ID: K954671
• Device Name: THE FREEDOM BED
• Applicant: Probed Medical Technologies, Inc.
• Product Code: IKZ · Physical Medicine
• Decision Date: Apr 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5225
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Freedom Bed PAR 3 is used to automatically reposition immobilized persons from side to side either manually or on a programmed schedule aide in the prevention of decubitus ulcers in bed ridden patients.

Device Story

Programmable, automatically/manually operated repositioning bed; prevents decubitus ulcers in immobilized patients. Input: user-defined settings (time, angle, speed) via microprocessor controller. Operation: 3-section platen with flexible hinges; center section rotates up to 30 degrees; outer sections rotate to support/contain user. Powered by 12 VDC actuators. Used in clinical or home settings; operated by patient or attendant. Output: physical repositioning of patient. Benefit: weight transfer, prevention of sliding/falling, increased patient independence, improved sleep quality.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

3-section platen with flexible hinges; 12 VDC powered actuators; microprocessor-based controller for time, angle, and speed adjustment. UL 544, CSA, and FCC compliant.

Indications for Use

Indicated for immobilized, bed-ridden patients requiring periodic repositioning to prevent decubitus ulcers.

Regulatory Classification

Identification

A powered patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and to aid circulation.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.

Submission Summary (Full Text)

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K954671

# 510(k) Summary of Safety and Effectiveness

ProBed Medical Technologies Inc.
Freedom Bed - Model PAR 3
APR - 1 1996

## 1. Submitter:

The 510(k) is submitted by ProBed Medical Technologies Inc., 44325 Yale Rd.W, Chilliwack, B.C., Canada V2R 4H2 Attn: Stephen B. Plummer. This 510(k) summary was prepared in September 1995.

## 2. Device name:

The 510(k) submission is for the ProBed Medical Technologies Inc., Freedom Bed™ Model PAR3.

## 3. Predicate device:

The device described in this submission is considered to be substantially equivalent to (list predicate). The predicate devices are legally marketed, having been found to be substantially equivalent through the 510(k) premarket notification process.

## 4. Device description:

The device is a programmable, automatically or manually operated repositioning bed designed for the prevention of decubitus ulcers. The device consists of 3 separate platen sections joined together with flexible hinges. The center section rotates left and right to a maximum of 30 degrees on each side, while the appropriate outer section rotates up to support and contain the sleeper. This provides a surface to transfer weight onto, as well as prevents the user from sliding or falling out of bed. The microprocessor based controller provides adjustment of time, angle and speed, as well as a choice of manual operation, automatic operation, or patient control. This allows most users to achieve independence from night time attendants and higher quality and duration of sleep. The bed has received UL 544, CSA, and FCC approvals.

## 5. Intended use:

The Freedom Bed PAR 3 is used to automatically reposition immobilized persons from side to side either manually or on a programmed schedule aide in the prevention of decubitus ulcers in bed ridden patients.

## 6. Comparison of technological characteristics:

We believe that the device has the same or similar technological features as compared to other devices currently manufactured or distributed in the United States. All 3 are electronically controlled and turn to a maximum of 30 degrees. The main difference is that while the predicate devices utilize air pressure to initiate the turning, the Freedom Bed uses 12 VDC powered actuators. Any variation in technology or difference of mechanism would not adversely affect the safety and effectiveness of the device.