PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905

K972123 · Smith · FMQ · Jul 25, 1997 · General Hospital

Device Facts

• Record ID: K972123
• Device Name: PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905
• Applicant: Smith
• Product Code: FMQ · General Hospital
• Decision Date: Jul 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Geriatric Products Restraints are for use by a responsible licensed healthcare professional to limit patient movement to the extent necessary for treatment, examination, protection of patient and others, or postural control. Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Device Story

Protective restraints designed to limit patient movement; used by licensed healthcare professionals in clinical settings. Device restricts physical mobility to facilitate medical treatment, examination, or postural support; ensures safety of patient and others. Operation involves manual application by staff; no automated or electronic components. Benefits include controlled patient positioning and prevention of injury during care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical restraint device; materials and specifications not detailed in provided documentation. No electronic, software, or energy-based components.

Indications for Use

Indicated for patients requiring movement limitation for treatment, examination, patient/staff protection, or postural control. Restricted to use by licensed healthcare professionals under physician order.

Regulatory Classification

Identification

A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. E.J. Smith Geriatric Products Incorporated C/O Smith Associates P.O. Box 4341 Crofton, Maryland 21114

JUI 25 1997

Re : K972123 Protective Restraint Models #302,440,750, Trade Name: 850, and 905 Requlatory Class: I Product Code: FMQ June 3, 1997 Dated: Received: June 5, 1997

Dear Mr. Smith:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Smith

through 542 of the Act for devices under the Electronic Product Radiation Control 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 FDAfinding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

K. Olstad

Timo A 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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.K 972123...

510(k) Number (if known):

Device Name: Protective Rostraint

Classification Panel: 880.6760, 80FMQ

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Indications for Use:

The Geriatric Products Restraints are for use by a responsible licensed healthcare professional to limit patient movement to the extent necessary for treatment, examination, protection of patient and others, or postural control.

Foderal (U.S.A.) law restricts this device to sale by or on the order of a physician.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, f and General Hospital I 510(k) Number 2 3

Proscription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use