RELIANT CHARGER

K971768 · Walling Medical Equipment Co. · LKY · Sep 29, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971768
• Device Name: RELIANT CHARGER
• Applicant: Walling Medical Equipment Co.
• Product Code: LKY · Gastroenterology, Urology
• Decision Date: Sep 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5020
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Reliant Charger is used to cause engorgement of the penis for men that are having difficulty with organic or psychological impotence.

Device Story

Reliant Charger is a vacuum-based device designed to treat male impotence. It functions by creating a vacuum environment around the penis to induce engorgement. The device is intended for use by patients in a home setting. By facilitating penile erection, the device assists patients in managing erectile dysfunction, potentially improving sexual function.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Vacuum-based penile engorgement device. Mechanical operation. No software or electronic algorithm components described.

Indications for Use

Indicated for men experiencing organic or psychological impotence to facilitate penile engorgement.

Regulatory Classification

Identification

External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.

Special Controls

*Classification.* Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 1997

Mr. Allan Walling President Walling Medical Equipment, Inc. 3000 Candide Lane McKinney, Texas 75070

Re: K971768

Reliant Charger (RC-1) Dated: August 5, 1997 Received: August 11, 1997 Regulatory class: unclassified Product code: 78 LKY

Dear Mr. Walling:

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 (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 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 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 Radiation Control provisions, or other Federal laws or regulations.

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.

H.J. Liao Yu
Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K971768 Device Name: Reliant Charger

Indications for Use:

The Reliant Charger is used to cause engorgement of the penis for men that are having difficulty with organic or psychological impotence.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Rolar D. Sutherly, I

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use U (Per 21 CFR 801.109)

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OR

Over-The-Counter Use