PROVEST-PROTECTIVE RESTRAINT

K971561 · Jemm Medical Products · FMQ · Jul 14, 1997 · General Hospital

Device Facts

• Record ID: K971561
• Device Name: PROVEST-PROTECTIVE RESTRAINT
• Applicant: Jemm Medical Products
• Product Code: FMQ · General Hospital
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Indications for Use

ProVest should only be used with proper medical authorization. The licensed medical practitioner will determine when a restraint is indicated, the type of device needed, and the duration and frequency of use of the device. ProVest is intended to be used as a gentle reminder to remain in the bed or wheelchair and for postural support.

Device Story

ProVest is a protective restraint device used in clinical or home settings to provide postural support and serve as a gentle reminder for patients to remain in a bed or wheelchair. It is intended for use under the direction of a licensed medical practitioner who determines the necessity, type, duration, and frequency of use. The device functions as a physical aid to assist with patient positioning and safety.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Protective restraint device; mechanical design for postural support and patient positioning.

Indications for Use

Indicated for patients requiring postural support or a reminder to remain in a bed or wheelchair, as determined by a licensed medical practitioner.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K971561

Ms. Angelita Kowalewsky 'President Jemm Medical Products 42909 Alep Street Lancaster, California 93536

JUL 1 4 1997

Re : K971561 Provest-Protective Restraint Trade Name: Requlatory Class: I Product Code: FMQ Dated: March 1, 1997 Received: April 29, 1997

Dear Ms. Kowalewsky:

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 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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 - Ms. Kowalewsky

through 542 of the Act for devices under the Electronic enroduct 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 FDA finding 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 requlation (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,

Timo thy 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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## 510(k) Number: K971561

## Device Name: ProVest - Protective Restraint

:

Indications for use:

ProVest should only be used with proper medical authorization. The licensed medical practitioner will determine when a restraint is indicated, the type of device needed, and the duration and frequency of use of the device. ProVest is intended to be used as a gentle reminder to remain in the bed or wheelchair and for postural support.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | 971561 |

| Prescription Use (Per 21 CFR 801.109) | <span></span> |
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OR

| Over - The - Counter Use | |
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| (Optional Format 1, 2-96) | |

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