Viberect Penile Vibratory Stimulation Device

• K Number: K142304
• Device Name: Viberect Penile Vibratory Stimulation Device
• Manufacturer: REFLEXONIC, LLC
• Date Cleared: 2014-10-03 ( 46 days)
• Product Code: KXQ
• Regulation Number: 884.5960

Intended Use

Viberect® Penile Vibratory Stimulation Device is a hand held medical device to provoke erections for men who experience erectile dysfunction.

Device Description

The Viberect® device is a hand held medical device intended for use by the person at home for the purpose of stimulating the nerves of the penis for the purpose of activating several nerve reflexes which are responsible for initiation of penile erection and rigidity. This device is unique in that it has two gentle vibrating motors that allow simultaneous vibratory stimulation of both the upper and lower surfaces of the penis. As each side of the male penis is supplied by different nerves, simultaneous stimulation of the upper and lower surfaces increases sexual response. The device is held by one hand easily, like holding a hair straightener. The penis is placed between the vibrating 'soft pads'. As pressure is increased to the device, it is automatically activated. The device can be deactivated by releasing the hand pressure which immediately shuts off the vibrating 'soft pads'. The touch pad on the Viberect provides further control by the user whereby the user can increase and decrease the frequency of vibration according to comfort and response. Finally, there are individual modes for the vibratory movement of the upper housing only, lower housing only, and both. The device is powered by rechargeable batteries. Vibratory stimulation for approximately 3-10 minutes is recommended.

Predicate Devices

K110566

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical vibration and user control, with no mention of AI/ML algorithms for analysis, decision-making, or adaptation.

Therapeutic

Yes
The device is described as "a hand held medical device to provoke erections for men who experience erectile dysfunction" and its purpose is to stimulate nerves to initiate penile erection and rigidity, which directly addresses a medical condition (erectile dysfunction).

Diagnostic

No
The device's intended use is to provoke erections by stimulating nerves, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, hand-held device with vibrating motors, soft pads, and rechargeable batteries, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Viberect® Penile Vibratory Stimulation Device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease.
• The Viberect device is a physical device that directly stimulates the penis externally. It does not analyze any biological samples.
• Its intended use is to provoke erections through physical stimulation, not to diagnose or monitor a condition based on biological samples.

The description clearly indicates it's a hand-held medical device for external physical stimulation.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Viberect® Penile Vibratory Stimulation Device is a hand held medical device indicated to provoke erections for men who experience erectile dysfunction. For Over-the-Counter (OTC) use.

Product codes (comma separated list FDA assigned to the subject device)

KXQ

Device Description

The Viberect® device is a hand held medical device intended for use by the person at home for the purpose of stimulating the nerves of the penis for the purpose of activating several nerve reflexes which are responsible for initiation of penile erection and rigidity. This device is unique in that it has two gentle vibrating motors that allow simultaneous vibratory stimulation of both the upper and lower surfaces of the penis. As each side of the male penis is supplied by different nerves, simultaneous stimulation of the upper and lower surfaces increases sexual response.

The device is held by one hand easily, like holding a hair straightener. The penis is placed between the vibrating 'soft pads'. As pressure is increased to the device, it is automatically activated. The device can be deactivated by releasing the hand pressure which immediately shuts off the vibrating 'soft pads'. The touch pad on the Viberect provides further control by the user whereby the user can increase and decrease the frequency of vibration according to comfort and response. Finally, there are individual modes for the vibratory movement of the upper housing only, lower housing only, and both. The device is powered by rechargeable batteries. Vibratory stimulation for approximately 3-10 minutes is recommended.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

penis

Indicated Patient Age Range

men who experience erectile dysfunction

Intended User / Care Setting

Home / Over-the-Counter (OTC) use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Data:

• Biocompatibility testing in accordance with ISO 10993-1
• Electrical Safety testing in accordance with IEC 60601-1
• Electromagnetic Compatibility testing in accordance with IEC 60601-1-2
• Usability testing
• Shipping testing
• Drop testing
• Cleaning testing

Results: The Viberect device meets all the requirements for overall design, biocompatibility, and electrical safety, and has been confirmed that the output meets the design inputs and specifications. The Viberect device passed all testing stated above as shown by the acceptable results obtained. The Viberect device complies with the applicable voluntary standards for biocompatibility, electrical safety and electromagnetic compatibility. The device passed all the testing in accordance with national and international standards.

Clinical Performance Data:
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The predicate device, Viberect has been on the market for several years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
Usability testing was performed and determined to be acceptable to support OTC indications for use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K110566

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 884.5960 Genital vibrator for therapeutic use.

(a)
Identification. A genital vibrator for therapeutic use is an electrically operated device intended and labeled for therapeutic use in the treatment of sexual dysfunction or as an adjunct to Kegel's exercise (tightening of the muscles of the pelvic floor to increase muscle tone).(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in § 884.9.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest a sense of community and support.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 3. 2014

Reflexonic, LLC % Julie Powell Vice President, Ouality Assurance Emergo Group 816 Congress Ave., Suite 1400 Austin, TX 78701

Re: K142304

Trade/Device Name: Viberect Penile Vibratory Stimulation Device Regulation Number: 21 CFR& 884.5960 Regulation Name: Genital Vibrator for Therapeutic Use Regulatory Class: II Product Code: KXQ Dated: August 15, 2014 Received: August 18, 2014

Dear Julie Powell.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA mav publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K142304

Device Name Viberect® Penile Vibratory Stimulation Device

Indications for Use (Describe)

Viberect® Penile Vibratory Stimulation Device is a hand held medical to provoke erections for men who experience erectile dysfunction.

Type of Use (Select one or both, as applicable)

• Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

for

Viberect® Penile Vibratory Stimulation Device

1. Submission Sponsor

Reflexonic, LLC 915 Toll House Avenue, Suite 205 Frederick, MD 21701 USA Phone: [phone] Fax: [phone] Contact: Dr. Kambiz Tajkarimi, President

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: PHONE Office Phone: [phone] Fax: [phone] Contact: Julie Powell, VP, QA Email: [e-mail]

3. Date Prepared

August 15, 2014

4. Device Identification

Viberect® Penile Vibratory Stimulation Device (Viberect) Trade/Proprietary Name: Common/Usual Name: Vibrator Classification Name: Vibrator for Therapeutic Use Classification Regulation: 884.5960 Product Code: KXQ Device Class: Class II Classification Panel: Obstetrics /Gynecology

5. Legally Marketed Predicate Device(s)

Viberect® Penile Vibratory Stimulation Device Manufactured by Reflexonic, LLC 510(k) K110566

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6. Device Description

The Viberect® device is a hand held medical device intended for use by the person at home for the purpose of stimulating the nerves of the penis for the purpose of activating several nerve reflexes which are responsible for initiation of penile erection and rigidity. This device is unique in that it has two gentle vibrating motors that allow simultaneous vibratory stimulation of both the upper and lower surfaces of the penis. As each side of the male penis is supplied by different nerves, simultaneous stimulation of the upper and lower surfaces increases sexual response.

The device is held by one hand easily, like holding a hair straightener. The penis is placed between the vibrating 'soft pads'. As pressure is increased to the device, it is automatically activated. The device can be deactivated by releasing the hand pressure which immediately shuts off the vibrating 'soft pads'. The touch pad on the Viberect provides further control by the user whereby the user can increase and decrease the frequency of vibration according to comfort and response. Finally, there are individual modes for the vibratory movement of the upper housing only, lower housing only, and both. The device is powered by rechargeable batteries. Vibratory stimulation for approximately 3-10 minutes is recommended.

7. Indication for Use Statement

Viberect " Penile Vibratory Stimulation Device is a hand held medical device indicated to provoke erections for men who experience erectile dysfunction. For Over-the-Counter (OTC) use.

8. Substantial Equivalence Discussion

The following table compares the Viberect OTC device to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Table 12A – Device Comparison Chart: Similarities and Differences
	Proposed Device	Predicate Device
Manufacturer	Reflexonic, LLC	Reflexonic, LLC	Significant Differences
Trade Name	Viberect Penile Vibratory
Stimulation Device	Viberect Penile Vibratory
Stimulation Device
510(k) Number	NA	K110566	N/A
Product Code	KXQ	KXQ	Same
Regulation Number	884.5960	884.5960	Same
Regulation Name	Vibrator for Therapeutic Use	Vibrator for Therapeutic Use	Same
Indications for Use	Viberect Penile Vibratory
Stimulation Device is a hand
held medical device indicated
to provoke erections for men
who experience erectile
dysfunction.	Viberect Penile Vibratory
Stimulation Device is a hand
held medical device indicated
to provoke erections for men
who experience erectile
dysfunction and to provoke
ejaculation for spinal cord
injured men.	Removed the indication for use in
spinal cord injured men, as
recommended by the FDA
Intended for
Prescription or OTC	OTC	Prescription	For OTC use; Usability study
performed (per discussion with
	Proposed Device	Predicate Device
Manufacturer	Reflexonic, LLC	Reflexonic, LLC	Significant Differences
Trade Name	Viberect Penile Vibratory
Stimulation Device	Viberect Penile Vibratory
Stimulation Device
Use			the FDA); refer to Section 18 and
Exhibit 18-D and 18-E for
Usability Protocol and Report
Class	II	II	Same
Provided Sterile or
Non-Sterile	Non-Sterile	Non-Sterile	Same
Basic Design	Hand held vibratory device
which upon activation
stimulates the nerves of the
penis. This device has two
gentle vibrating motors that
allow simultaneous vibratory
stimulation of both surfaces
(top and bottom) of the penis.	Hand held vibratory device
which upon activation
stimulates the nerves of the
penis. This device has two
gentle vibrating motors that
allow simultaneous vibratory
stimulation of both surfaces
(top and bottom) of the
penis.	Same
Length	Approximately 10 inches	Approximately 10 inches	Same
Width	Approximately 2 inches (at
widest point)	Approximately 2 inches (at
widest point)	Same
Reusable	Yes – provided with cleaning
instructions	Yes - provided with cleaning
instructions	Same
Power Source	Rechargeable Nickel Metal
Hydride (NiMH) batteries.
Rechargeable (Ni-Cd)
6/1.2V/0.35Ah. The battery
will last a minimum of 20
minutes (at 100hz and 2.5mm).	Rechargeable Nickel Metal
Hydride (NiMH) batteries.
Rechargeable (Ni-Cd)
6/1.2V/0.35Ah. The battery
will last a minimum of 20
minutes (at 100hz and
2.5mm).	Same
Patient Contacting
Materials	Vibrating Soft Pads
Polyurethane/ Polyurethane
Foam
(IROGRAN®)	Vibrating Soft Pads
Polyurethane/ Polyurethane
Foam
(IROGRAN®)	Same
Frequency	70-110 Hz	70-110 Hz	Same
Amplitude Range
(peak to valley)	2 – 3 mm	2 – 3 mm	Same
Adjustability of above
parameters	Full range by touch pad control	Full range by touch pad
control	Same
Type of motion	Pulsatile	Pulsatile	Same
Auto safety shut off	Yes	Yes	Same
Complies with ISO
10993-1	Yes	Yes	Same
Charger, main voltage	100-120 / 200-240 volts	100-120 / 200-240 volts	Same
Electrical Safety
Testing Passed	Yes	Yes	Same

Device Comparison Chart: Similarities and Differences

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9. Non-Clinical Performance Data

The following testing has been performed and determined to be acceptable to support substantial equivalence:

• Biocompatibility testing in accordance with ISO 10993-1 .
• . Electrical Safety testing in accordance with IEC 60601-1
• Electromagnetic Compatibility testing in accordance with IEC 60601-1-2 ●
• Usability testing

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• Shipping testing
• Drop testing
• Cleaning testing

As part of demonstrating safety and effectiveness of Viberect device and in showing substantial equivalence to the predicate device that are subject to this 510(k) submission, Reflexonic, LLC completed a number of tests. The Viberect device meets all the requirements for overall design, biocompatibility, and electrical safety, and has been confirmed that the output meets the design inputs and specifications. The Viberect device passed all testing stated above as shown by the acceptable results obtained.

The Viberect device complies with the applicable voluntary standards for biocompatibility, electrical safety and electromagnetic compatibility. The device passed all the testing in accordance with national and international standards.

10. Clinical Performance Data

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The predicate device, Viberect has been on the market for several years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

Usability testing was performed and determined to be acceptable to support OTC indications for use.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. The Viberect device has reduced the indications for use from the predicate device and has the identical technological characteristics as the predicate device. The new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.