SOMA 900 TRANSPORT BED

K971546 · Nova Technologies, Inc. · FNL · Jul 10, 1997 · General Hospital

Device Facts

• Record ID: K971546
• Device Name: SOMA 900 TRANSPORT BED
• Applicant: Nova Technologies, Inc.
• Product Code: FNL · General Hospital
• Decision Date: Jul 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5100
• Device Class: Class 2

Intended Use

The Soma™ Safe Transport Bed is to be used for the management of patients who are excessive in size and those who are the most difficult to care for. The use of this device will assure the prevention of personal care injury to the patient and staff.

Device Story

Soma Safe Transport Bed; mechanical patient transport device. Designed for bariatric or difficult-to-manage patients. Used in clinical settings to facilitate safe movement; prevents injury to patients and healthcare staff during transport. Operates as a specialized bed frame/stretcher system. No electronic or software components described.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical transport bed for bariatric patients. No electronic, software, or energy-based components. Materials and specifications not detailed in provided documentation.

Indications for Use

Indicated for management of patients of excessive size and those difficult to care for, to prevent injury to patients and staff.

Regulatory Classification

Identification

An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

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 § 880.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Samuel N. Paul Executive Vice President Vivax Medical Corporation 545 Middle Street Bristol, Connecticut 06010

JUL 1 0 1997

Re: K971546 Soma 900 Transport Bed Trade Name: . Requlatory Class: II Product Code: FNL Dated: April 22, 1997 Received: April 28, 1997

Dear Mr. Paul:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531

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Page 2 - Mr. Paul

through 542 of the Act for devices under the Electronic chrough 542 or the noorol provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sia nequivalence of your device to a legally Finding of bubbeansfarice results in a classification for your marketed predicate acits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regaracian ostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compreator as (od advertising of your device, please contact che office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to the regulation chercica) Hibbidiang II Other general information on your responsibilities under the Act may be Information on Journal Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fqa.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health '

Enclosure

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510(k) Number (if known): K971546

Device Name: Soma™ Safe Transport Bed

Indications For Use:

The Soma™ Safe Transport Bed is to be used for the management of patients who are excessive in size and those who are the most difficult to The use of this device will assure the prevention of personal care for. injury to the patient and staff.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) *falava Cuconte*
Division of Dental, Infection Control,
and General Heepita! Davicos
510(k) Number *K971546*
Prescription Use **__** OR Over The Counter Use

(Per 21 CFR 801.109)