VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR

• K Number: K141919
• Device Name: VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR
• Manufacturer: AD REM TECHNOLOGY SARL
• Date Cleared: 2015-06-16 ( 336 days)
• Product Code: NGX GXY
• Regulation Number: 890.5850

Intended Use

The VEINOPLUS® SPORT is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Description

The VEINOPLUS® SPORT, like a number of legally marketed predicate devices is a traditional battery powered muscle stimulator. It is portable, hand-held device, equipped with one single channel intended to stimulate the calf muscles or other muscles of the body (for example thighs, arms, buttock, back, shoulder or abdomen). The VEINOPLUS® SPORT device has only one operating mode, called program, stored in the internal memory. The output stimulus is low-voltage, low frequency with rectangular voltage waveform. The device is housed in a plastic enclosure, and it is powered by an alkaline 9V primary battery. The accessories include the output cables, battery, user manual and electrode pads. No provisions are made for AC adapters, so the device cannot be connected to line under any circumstances. The VEINOPLUS® SPORT device is supplied with all accessories (as listed below) necessary for a safe and effective session of stimulation. Main unit, cable, the pair of electrodes, battery, lanyard and user manual are packaged in carrying case then packaged in a carton box with printed messages. Refer to the picture in Section 12 Device Description. List of accessories: - 1pair of electrodes VEINOPLUS® Pack. Self-adhesive. Oval shape. Size 8x13 cm. Low resistance. This includes a Hydrogel for the electrodes (Refer to Sections 19 and 23F). - 1 conductor cable for connecting the electrodes. Approximate length (w/o plug) 135 cm. - 1 instruction manual - 1 9V alkaline battery - 1 lanyard - 1 carrying case: L22.5*W4.5*H17cm.

Predicate Devices

K072252, K083140

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on traditional electrical muscle stimulation technology and compliance with relevant safety and performance standards. There is no mention of AI or ML in the document.

Therapeutic

No
The device is intended to stimulate healthy muscles to improve muscle performance, not to treat or diagnose a disease or condition.

Diagnostic

No

The device is intended to stimulate healthy muscles to improve and facilitate muscle performance, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "traditional battery powered muscle stimulator" and lists hardware components such as a plastic enclosure, battery, cables, and electrode pads. While software verification is mentioned, the device is clearly a hardware-based system with embedded software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the VEINOPLUS® SPORT is not an IVD (In Vitro Diagnostic) device.

Here's why:

• Intended Use: The intended use is to "stimulate healthy muscles in order to improve and facilitate muscle performance." This is a physical intervention on the body, not a diagnostic test performed on samples taken from the body.
• Device Description: The device is described as a "traditional battery powered muscle stimulator." It applies electrical stimulation to muscles.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) or to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.

IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. The VEINOPLUS® SPORT is a therapeutic/performance enhancement device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The VEINOPLUS® SPORT is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

Product codes

NGX, GXY

Device Description

The VEINOPLUS® SPORT, like a number of legally marketed predicate devices is a traditional battery powered muscle stimulator. It is portable, hand-held device, equipped with one single channel intended to stimulate the calf muscles or other muscles of the body (for example thighs, arms, buttock, back, shoulder or abdomen). The VEINOPLUS® SPORT device has only one operating mode, called program, stored in the internal memory.

The output stimulus is low-voltage, low frequency with rectangular voltage waveform. The device is housed in a plastic enclosure, and it is powered by an alkaline 9V primary battery. The accessories include the output cables, battery, user manual and electrode pads. No provisions are made for AC adapters, so the device cannot be connected to line under any circumstances.

The VEINOPLUS® SPORT device is supplied with all accessories (as listed below) necessary for a safe and effective session of stimulation. Main unit, cable, the pair of electrodes, battery, lanyard and user manual are packaged in carrying case then packaged in a carton box with printed messages. Refer to the picture in Section 12 Device Description.

List of accessories:

• 1pair of electrodes VEINOPLUS® Pack. Self-adhesive. Oval shape. Size 8x13 cm. Low resistance. This includes a Hydrogel for the electrodes (Refer to Sections 19 and 23F).
• 1 conductor cable for connecting the electrodes. Approximate length (w/o plug) 135 cm.
• 1 instruction manual
• 1 9V alkaline battery
• 1 lanyard
• 1 carrying case: L22.5W4.5H17cm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Calf muscles and other body parts (arms, buttocks, back (neck/shoulders).

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Healthy user
Home, hospital, gym, etc.

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)

Compliance to applicable voluntary standards includes IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 and ISO 14971. The gel of electrodes was tested according ISO 10993-5 and ISO 10993-10 Biocompatibility standards. In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA guidance for the content of premarket submissions for software contained in Medical Devices. A usability study support as well that the user can operate the device in a safe and effective manner with labeling supplied with the device. The safety and performance of the device is supported by testing with safety and performance standards IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10 standards. The differences between VEINOPLUS® SPORT® and the predicate devices do not raise new issues of safety and effectiveness.

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

Not Found

Predicate Device(s)

K072252, K083140

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).

Summary

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

June 15, 2015

Ad Rem Technology SARL c/o Norman F. Estrin, PhD Estrin Consulting Group, LLC 9109 Copenhaver Drive Potomac, MD 20854

Re: K141919

Trade/Device Name: Veinoplus® Sport Neuromuscular Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, GXY Dated: May 18, 2015 Received: May 19, 2015

Dear Dr. Estrin:

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. Iisting 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 may 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.

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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" (21CFR 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,

Felipe Aquel -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141919

Device Name

VEINOPLUS® SPORT Neuromuscular Stimulator

Indications for Use (Describe) The VEINOPLUS® SPORT is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo and contact information for Ad Rem Technology. The logo features the company name in a stylized font, with the words "Ad Rem" in a larger font size and a blue color, and the word "TECHNOLOGY" in a smaller font size. Below the logo is the text "ISO 13485:2003 and ISO 9001:2008", followed by the address "162, rue du Faubourg Saint-Honoré, 75008 Paris - France", telephone number "[phone]", fax number "[phone]", email address "[e-mail]", and website address "www.adremtechnology.fr".

510(k) SUMMARY (Clean) Ad Rem Technology Veinoplus Sport Neuromuscular Stimulator

| Sponsor identification | Ad Rem Technology SARL
162 Rue du Faubourg Saint- Honoré
75008 Paris, France
Ms. Noémie Dumérain, Quality and Regulatory Affairs Manager,
[e-mail]
Tel: + 33 (0)1.42.60.00.22; Fax: + 33 (0)1.42.60.00.63 |
|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
registration number: | 3005671018 |
| Date of preparation | June 13, 2014 |
| Contact person | Norman F. Estrin, Ph.D.
Managing Partner
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: [phone]
Email: [e-mail] |
| Authorized Agent in
the United States | Norman F. Estrin, Ph.D.
Managing Partner
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: [phone]
Email: [e-mail] |
| Proprietary Name | Veinoplus® Sport Neuromuscular Stimulator |
| Trade name | VEINOPLUS® SPORT |
| Device Classification
Name, Product Code,
Reviewing Panel,
Regulatory Class,
(Regulation) | Device, Stimulator, Muscle, Powered, For Muscle Conditioning
NGX Physical Medicine, Class II (21 CFR 890.5850)
Electrode, cutaneous
GXY Neurology, Class II (21 CFR 882.1320) |
| Indications for
use: | The VEINOPLUS® SPORT is intended to stimulate healthy
muscles in order to improve and facilitate muscle performance. |

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Device Description

Design and features:

The VEINOPLUS® SPORT, like a number of legally marketed predicate devices is a traditional battery powered muscle stimulator. It is portable, hand-held device, equipped with one single channel intended to stimulate the calf muscles or other muscles of the body (for example thighs, arms, buttock, back, shoulder or abdomen). The VEINOPLUS® SPORT device has only one operating mode, called program, stored in the internal memory.

The output stimulus is low-voltage, low frequency with rectangular voltage waveform. The device is housed in a plastic enclosure, and it is powered by an alkaline 9V primary battery. The accessories include the output cables, battery, user manual and electrode pads. No provisions are made for AC adapters, so the device cannot be connected to line under any circumstances.

The VEINOPLUS® SPORT device is supplied with all accessories (as listed below) necessary for a safe and effective session of stimulation. Main unit, cable, the pair of electrodes, battery, lanyard and user manual are packaged in carrying case then packaged in a carton box with printed messages. Refer to the picture in Section 12 Device Description.

List of accessories:

• 1pair of electrodes VEINOPLUS® Pack. Self-adhesive. Oval shape. Size 8x13 cm. Low resistance. This includes a Hydrogel for the electrodes (Refer to Sections 19 and 23F).
• 1 conductor cable for connecting the electrodes. Approximate length (w/o plug) 135 cm.
• 1 instruction manual
• 1 9V alkaline battery
• 1 lanyard
• 1 carrying case: L22.5W4.5H17cm. |
  | Predicate Devices | Veinoplus® (K072252)
  Compex® Sport Plus (K083140) |

Comparison of the indications for use with the predicate devices:

The proposed device, VEINOPLUS® SPORT, is substantially equivalent to both of its legally marketed Class II predicate devices:

• 1. The mode 1 (powered muscle stimulator, IPF) of the Veinoplus® with 510k K072252 (except for the indications for use).
• 2. The mode (program) "active recovery" of the Compex® Sport Plus with 510k K083140.

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Summary of technological characteristics of VEINOPLUS® SPORT with its two predicates Veinoplus® and Compex Sport Plus:

Device name:	VEINOPLUS® SPORT	Veinoplus® (mode 1 of stimulation)	Compex® Sport Plus (Program Active Recovery)
510k Number	K141919	K072252	K083140
Intended use:	Muscle electrical stimulation	Muscle electrical stimulation	Muscle electrical stimulation
Indications for use:	The VEINOPLUS® SPORT is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.	Increasing local blood circulation (common claim with predicates). Relaxation of muscle spasm/ Prevention or retardation of muscle disuse atrophy/ Muscle reeducation/ Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis/Maintaining or increasing range of motion.	Stimulate healthy muscles in order to improve or facilitate muscle performance.
Mode of Action:	The VEINOPLUS® SPORT contracts the muscles by electrical stimulation.	The Veinoplus stimulates the muscles, resulting in rhythmic muscles contraction, which then increases the blood flow.	The Active Recovery program produces muscle twitches at a very low frequency. Those twitches act like a massage and induce an increase of the blood flow and a faster reduction of the lactic acid blood level. It facilitates recovery of the stimulated muscles after active muscle training or competition.
Purpose:	Non-Medical	Medical	Non-Medical
Target Population:	Healthy user	Medical patient	Healthy user
Parts to be stimulated:	Calf muscles and other body parts (arms, buttocks, back (neck/shoulders).	Calf muscles	Legs/feet, arms/hands, buttock, back, shoulder or abdomen)
Where used:	Home, hospital, gym, etc.	Home, hospital, gym, etc.	Data unknown
Device name:	VEINOPLUS® SPORT	Veinoplus® (mode 1 of
stimulation)	Compex® Sport Plus
(Program Active Recovery)
OTC/Rx Only
information :	OTC use	Prescription use	OTC use
Energy
delivered:	Electrical	Electrical	Electrical
Technical information:
Power Source:	One Internal 9 V alkaline
battery.
Types: 522, 6LR61,
MN1604
Shape: rectangular
Size: 48x25x16 mm;
Volume: 20 cm³	One Internal 9 V alkaline
battery
Types: 522, 6LR61,
MN1604
Shape: rectangular
Size: 48x25x16 mm;
Volume: 20 cm³	One NIMH rechargeable
battery ( 4.8V ≥1200 mA/h )
(4 cells pack of 1.2V)
Type: 4H-AA1500
Shape: cylindrical
Size: 1 cell = 14 mm x
47mm , diameter 14 mm;
Volume: 7.3 cm³
Number of
output modes	1 mode/program	2 modes/programs :
Mode 1 : EMS
Mode 2 : TENS	9 modes/programs :
Potentiation
Endurance
Strength
Resistance
Active recovery
Recovery plus
Explosive strength
Pre warm-up
Massage
Timer range	30 minutes	Mode 1: 20 minutes
Mode 2: 20 minutes	Potentiation : 3' 27''
Endurance: 50' 23''+ 5'03'' of
optional warm up
Strength: 22'07''23''+ 5'03'' of
optional warm up
Resistance: 27'33''23''+ 5'03''
of optional warm up
Active recovery: 26'40''23''+
5'03'' of optional warm up
Recovery plus: 24'20''
Explosive strength: 25'18''
Pre warm up: 25'03''
Massage: 20'03''
Number of
output
channels:	1	1	4
Automatic
overload trip	NO	NO	NO
Automatic no
load trip	NO	NO	YES
Accessories:	Electrodes, cable, battery	Electrodes, cable, battery	Electrodes, cable, Battery
Device name:	VEINOPLUS® SPORT	Veinoplus® (mode 1 of stimulation)	Compex® Sport Plus (Program Active Recovery)
		(same model and manufacture as Veinoplus Sport)	charger.

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| Waveform | Monophasic rectangular
asymmetrical | Monophasic rectangular
asymmetrical | Biphasic rectangular
symmetrical |
|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Max Output
Voltage | 50 V@ 500 Ohm | 50 V@ 500 Ohm | 60 V@ 500 Ohm (each
phase) |
| Max Output
Current | 100 mA@ 500 Ohm | 100 mA@ 500 Ohm | 120 mA @ 500 Ohm (each
phase) |
| Max Phase
Charge (µC) | 24μC @500Ω | 24μC @500Ω | 48µC (each phase)
@500Ω |
| Maximum
current density
(mA/cm2, r.m.s.) |