PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT.

K972338 · Geriatric Products, Inc. · FMQ · Jul 24, 1997 · General Hospital

Device Facts

• Record ID: K972338
• Device Name: PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT.
• Applicant: Geriatric Products, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Jul 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1
• Attributes: Therapeutic

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

Device Story

Protective restraint device (Models 302, 440, 750, and A30" x 30" Belt) designed to limit patient movement. Used by licensed healthcare professionals in clinical settings to facilitate treatment, examination, or postural control. Device restricts patient motion to ensure safety of patient and others. Prescription-only device.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical restraint device; Class I, Product Code FMQ; 21 CFR 890.3910.

Indications for Use

Indicated for patients requiring movement limitation for treatment, examination, safety, or postural control, as determined by a licensed healthcare professional.

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 Smīth Associates P.O. Box 4341 Crofton, Maryland 21114

JUL 2 4 1997

Re : K972338 Protective Restraint (Models #302,440,750 Trade Name: and A30" x 30" Belt Regulatory Class: I Product Code: FMQ Dated: June 19, 1997 Received: June 23, 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 reqistration, listinq of devices, good 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ್ಗೆ 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 regulation (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 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 chrough 312 or on 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 FDA described in your sial equivalence of your device to a legally rinding of babbandaa-ice results in a classification for your markets promits 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 regaraciamostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact che 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 at fes coll free hamber (6:3)/www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

K. Wilmoth

hy A. Ulatowski Timot Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K972338

Page 1 of 1

510(k) Number (if known):

Device Name: Protective Restraint

Classification Panel: 890.3910, 89KID

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.

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

RELEASED
23 JUN 97 15 20
FDA/CDRH/ODE/DM

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) *Palucia Crucesite*
Division of Dental, Infection Contrai,
and General Hospital Devices
510(k) Number K972338

Prescription Use
(Per 21 CFR 801.109) ✓ OR Over-the-Counter Use

SK-56

OM