POCKET RESCUE

K970688 · Cheen Houng Ent. Co. , Ltd. · KGB · Sep 26, 1997 · Anesthesiology

Device Facts

• Record ID: K970688
• Device Name: POCKET RESCUE
• Applicant: Cheen Houng Ent. Co. , Ltd.
• Product Code: KGB · Anesthesiology
• Decision Date: Sep 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5570
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Cheen Houng Pocket Rescue is indicated for mouth to mask ventilation of a non-breathing adult.

Device Story

Pocket Rescue is an exhaled air pulmonary resuscitator; used for mouth-to-mask ventilation of non-breathing adults. Device facilitates rescue breathing by providing a barrier between rescuer and patient; includes optional oxygen port for supplemental oxygen delivery. Operated by trained rescuers or healthcare providers in emergency settings. Device functions as a physical interface to deliver exhaled air to patient airway; assists in maintaining patient oxygenation during respiratory arrest.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Exhaled air pulmonary resuscitator; includes optional oxygen port. Manual, non-powered device. Materials and design consistent with existing legally marketed resuscitators.

Indications for Use

Indicated for mouth-to-mask ventilation of non-breathing adult patients. Prescription use.

Regulatory Classification

Identification

A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.

Submission Summary (Full Text)

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K970688

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# CHEEN HOUNG ENTERPRISE CO. LTD.

23, ALLEY 11, LANE 65, SAN DREEN ST., SHULIN (238) TAIPEI SHENG, TAIWAN, R.O.C.

FAX: [phone]

TEL: [phone]

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

SEP 26 1997

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The Cheen Houng Enterprise Co., Ltd. Exhaled Air Pulmonary Resuscitators are similar in intended use, design, material selection, performance and function to Exhaled Air Pulmonary Resuscitators which are currently legally and safely marketed in the United States. No new technological characteristics that could affect safety or effectiveness have been introduced.

Therefore, it is our conclusion that the Cheen Houng Enterprise Co., Ltd. Exhaled Air Pulmonary Resuscitators are safe and effective for their intended function.

Signature Jay Wang

President of Cheen Houng Enterprise Co., Ltd.

Date 2/5/97

MALAYSIA PLANT: PLAXTRON INDUSTRIAL (M) SDN, BHD

Plot 28, Free trade Zone, Jelapang II, 30020 Ipoh, Perak, Malaysia

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP 26 1997

Mr. Jay Wang
Cheen Houng Enterprise Co., Ltd.
23, Alley 11, Lane 65, San Dreen Street
Shulin (238) Taipei Sheng
Taiwan R.O.C.

Re: K970688
"Pocket Rescue"
Regulatory Class: II (two)
Product Code: 73 KGB
Dated: August 10, 1997
Received: August 15, 1997

Dear Mr. Wang:

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 of the Act. The general controls provisions 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Jay Wang

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 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,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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INDICATION FOR USE

The Cheen Houng Pocket Rescue is indicated for mouth to mask ventilation of a non-breathing adult.

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☑ with optional oxygen port
prescription use

Charles Cido for AAC
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970668

CTC