HI-DOW-XP

K102598 · Hi-Dow International, Inc. · NUH · May 13, 2011 · Neurology

Device Facts

• Record ID: K102598
• Device Name: HI-DOW-XP
• Applicant: Hi-Dow International, Inc.
• Product Code: NUH · Neurology
• Decision Date: May 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K102598 · May 13, 2011	HI-DOW-XP	Hi-Dow International, Inc.	Post-market surveillance data (adverse event reports); Sales volume data; Peer-reviewed clinical literature	The sponsor utilized international post-market surveillance data (300,000+ units sold since 2007 with no reported adverse events) to establish safety for OTC use. Peer-reviewed literature was used to support the effectiveness of electrical stimulation for pain relief and muscle performance.	post-market surveillance; adverse event reporting; literature review; safety profile

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
International Post-Market Surveillance; Post-market surveillance / observational; Follow-up/Duration: 2007 to 2011; Study Period: 2007-2011	Users of the device in Europe and Asia; Sample Size: Over 300,000 units sold	Not applicable for this study	Safety (absence of adverse events)

Indications for Use

TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS: It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Story

Portable, battery-powered (3.7VDC) device providing TENS and PMS therapy. Operates via dual channels delivering programmed electrical pulses through adhesive electrode pads to target muscle groups. Features 6 operation modes. Used by patients in home settings for pain relief and muscle performance improvement. Device output consists of electrical stimulation causing minimal muscle contractions. Healthcare providers or patients use the device based on instructions for electrode placement and operation. Benefits include temporary pain relief and improved muscle performance without medical supervision.

Clinical Evidence

No clinical data. Evidence based on bench testing, compliance with international safety standards (EN60601-1, EN60601-1-2, EN60601-2-10), and software verification per FDA guidance. Effectiveness supported by literature regarding electrical stimulation for pain reduction and muscle performance.

Technological Characteristics

Portable, battery-powered (3.7VDC) dual-channel stimulator. Employs transcutaneous electrical nerve stimulation and powered muscle stimulation. Connectivity: None. Sterilization: N/A. Software: Embedded firmware. Standards: EN60601-1, EN60601-1-2, EN ISO 14971:2009, EN ISO 10993-1:2009, EN 60601-2-10:2000, EN 60601-1-4:1996.

Indications for Use

Indicated for adults experiencing temporary pain in shoulder, waist, back, neck, arms, or legs due to exercise or household strain; also indicated for stimulation of healthy muscles to improve/facilitate performance. No contraindications listed.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• T1040 (K060846)
• 5000Z OTC TENS (K033122)
• Sport Muscle Stimulator (K011880)

Submission Summary (Full Text)

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K102598 page 1 of 4

#### Hi-Dow International, Inc. li-Dow

2071 Comprasional Drive

St. Louis, Mimo 63146
[phone] Tel
[phone] Fax

## Section 5 - 510(k) Summary

Date of Summary Preparation: 1/17/2011

#### 1. Submitter's Identifications

Submitter's Name: Hi-Dow International, Inc. Address: 2071 Congressional Drive, Saint Louis MO 61346 Contact Person: Eric Chen Contact Email Address: [e-mail] Telephone: + 314 569 28888 Fax: + 314 997 08888

#### 2. Correspondent's Identifications

Correspondent's Name: Hi-Dow International, Inc. Address: 2071 Congressional Drive, Saint Louis MO 61346 Contact Person: Eric Chen Contact Email Address: [e-mail] Telephone: + 314 569 28888 Fax: + 314 997 08888

#### 3. Name of the Device

Device Classification Name: Stimulator, Muscle, Powered, Over-the-Counter Product Name: Powered Muscle Stimulator Trade Name: Hi-Dow Models: JQ-5C Classification Panel: Neurology Product Code: NGX NUH Device Classification: Class Contraindications: None

#### 4. The Predicate Devices

| K060846 T1040 | | TENS | 21CFR 882.5890 OTC |
|---------------|--------------------------------------|-------------------------|---------------------|
| | K033122 Prizm Medical Inc. | 5000Z OTC TENS | 21CFR 882.5890 OTC |
| | K01 1880 Compex Sport | Sport Muscle Stimulator | 21 CFR 890.5850 OTC |

#### 5. Device Description

The JQ-5C is a portable; battery powered (3.7VDC) multi function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS)

MAY 1 3 2011

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Hi-Dow® Hi-Dow International, Inc.

2071 Congressional Drive
St. Louis, Missouri 63146
[phone] Tel
[phone] x

#### qualities in one device.

Double channels that effectively transfers your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 6 modes of operation.

#### 6. Intended Use of Device

#### TENS:

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

#### PMS:

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

#### 7. Summary of Substantial Equivalence

Table : The difference between JQ-5C and Predicate T1040、5000Z and Compex.

| Quantity | JQ-5C | T1040 | 5000Z | Compex |
|---------------------------------------------|----------|---------|-------|-------------|
| Max Voltage over 10k, V | 84 | 154.1 | 226 | 126.8/103.3 |
| Max. Current over 10k, mA | 8.4 | 15.4 | 22.6 | 12.7/10.3 |
| Max. Voltage over 2.2k, V | 79.2 | 105.1 | 218 | 167.8/153.5 |
| Max. Current over 2.2k, mA | 39.6 | 47.8 | 99 | 76.3/69.8 |
| Max. Voltage over 500, V | 62.4 | 40.7 | 208 | 48 |
| Max. Current over 500, mA | 124.8 | 81.4 | 416 | 96.1 |
| Pulse Width, u seconds | 100 | 210 | 100 | 270 |
| Pulse Period, msec | 16.3~781 | 4.1-500 | 10 | 125 |
| Max. Pulse Frequency, Hz | 61.3 | 245 | 120 | 118 |
| Max Charge per Phase over 500Ω, μC | 17.92 | 16.9 | 3.4 | 32.3 |
| Max Current Density over 500Ω, mA/cm2 | 9.92 | 2.71 | 16.64 | 3.84 |
| Max. Average Power Density over 500 Ω.mWcm2 | 2.72 | 5.35 | | 10.2 |

#### 8. Substantial Equivalence:

The electrical stimulation provided by the JQ-5C is substantially equivalent to that commonly employed by muscle stimulators and TENS devices that have been cleared for marketing without prescription labeling; i.e, for OTC sale. The pulses in the waveform combinations are restricted

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# Hi-Dow International, Inc.

St. Louis, Missoчi 63146
[phone] Tel
[phone] P

in amplitude and duration to values consistent with the other device quoted above.

Technological characteristics, features, specifications, materials and intended uses of the JQ-5C are substantially equivalent to the quoted predicate device.

The differences that exist between the devices are insignificant in the terms of safety or effectiveness.

The JQ-5C has modes that offer substantially equivalent technical specifications, features and effective results as the predicate listed.

#### 9. Non-Clinical Tests Performed:

Compliance to applicable voluntary standards include: the Council Directive 93/42/EEC, as well as EN60601-1, EN60601-1-2, EN ISO 14971:2009, EN ISO 10993-1:2009, EN 60601-2-10:2000 + A1:2001-and-EN-60601-1-4:1996+A1:1999.

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.

#### 10. Conclusion:

The electrical stimulation provided by the JQ-5C is similar to the commonly employed muscle stimulators and TENS devices that have been cleared for marketing without prescription labeling.

The JQ-5C has the same intended uses and the similar technological characteristics as this OTC predicate. Moreover, verification and validation tests contained in this submission demonstrate that the differences in JQ-5C still maintain the same safety and effectiveness as that of the cleared device.

In other words, those engineering differences do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

Concerns of safe and proper use of electrodes and electrode pad placement have been fully addressed by making the user conscious of the proper placement of the electrodes and proper operations of the device through detail in the User's Instruction Manual.

We believe that there are no new safety or effectiveness issues concerning this device to be introduced.

The safety of the device, to be used for the proposed indications without medical prescriptions or supervision, is established by the fact that no adverse events have been reported sine 2007 with over 300,000 units sold without a prescription in Europe and Asia.

Over 300,000 units sold with no adverse effects reported, proves its specific technical, safety measures and features are safe and effective when used without medical supervision.

The effectiveness of the device for the proposed indications is supported by a number of articles in peer-reviewed publications, which demonstrate that electrical stimulation does improve muscle performance as well as temporary pain reduction.

Technological characteristics, features, specifications, materials and intended uses of the JQ-5C are substantially equivalent to the quoted predicate device.

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K102598 19 4.44

#### Hi-Dow Hi-Dow International, Inc.

St. Lonis, Missouri 63146
[phone] Ted
[phone] Px

The differences that exist between the devices are insignificant in the terms of safety or effectiveness.

The JQ-5C has modes that offer substantially equivalent technical specifications, features and effective results as the predicate listed. ·

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing human services, knowledge, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Hi-Dow International Inc % Mr. Eric Chen 2071 Congressional Drive St Louis, Missouri 63146

MAY 1 3 2011

Re: K102598

Trade/Device Name: Hi-Dow Model JQ-5C Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX Dated: April 27, 2011 Received: May 4, 2011

Dear Mr Chen:

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 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

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Page 2 - Mr. Eric Chen

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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

AK vs. Rh
for

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K102598 pg 1 of 1

#### Hi-Dow Hi-Dow International, Inc.

71 Comgreacional Drive
St. Louis, Missoni 63146
[phone] Ted
[phone] Fax

## Section 4 - Indications for Use

510(k) Number (if known): K102598

Device Name: Powered Muscle Stimulator Models: JQ-5C

Indications for Use:

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Prescription Use

AND/OR

Over-The-Counter Use X

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ion (ODE)

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(Divisi Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102598