H-WAVE

K103738 · Electronic Waveform Laboratory, Inc. · IPF · Jun 1, 2011 · Physical Medicine

Device Facts

• Record ID: K103738
• Device Name: H-WAVE
• Applicant: Electronic Waveform Laboratory, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Jun 1, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

1. Relaxation of muscle spasms; 2. Prevention or retardation of disuse atrophy; 3. Increasing local blood circulation; 4. Muscle re-education; 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and 6. Maintaining or increasing range of motion.

Device Story

H-Wave (model H4) is a portable, battery-operated electrical muscle stimulator. Device features two channels, lead wires, self-adhesive electrodes, and LCD display. User selects frequency (1-70 Hz) and intensity via buttons and dials. Device delivers therapeutic muscle contractions. Used in clinical or home settings under physician instruction. Output provides muscle re-education, spasm relaxation, and circulation improvement. Includes automatic no-load trip and patient override control. Benefits include prevention of disuse atrophy and post-surgical venous thrombosis.

Clinical Evidence

No clinical data. Verification and validation testing, including failure analysis of hardware and software, were conducted to ensure safety and effectiveness. Device conforms to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10 standards.

Technological Characteristics

Portable battery-operated (7.2V Ni-MH) electrical stimulator. ABS plastic housing. Two-channel galvanic isolation. Regulated voltage output (1-70 Hz). Includes LCD display, timer (0-60 min), and automatic no-load trip. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10. Software-controlled.

Indications for Use

Indicated for patients requiring muscle stimulation for spasm relaxation, prevention of disuse atrophy, increased local blood circulation, muscle re-education, post-surgical calf muscle stimulation to prevent venous thrombosis, and maintenance or increase of range of motion.

Regulatory Classification

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.

Predicate Devices

• H-Wave (model P-4), Electronic Waveform Lab, Inc. (K915230)

Submission Summary (Full Text)

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# 1343 X

JUN - 1 2011

### 510(k) Summary Electronic Waveform Lab Inc.'s H-Wave® Electrical Stimulator (model H4)

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Electronic Waveform Lab, Inc. 5702 Bolsa Ave. Huntington Beach, CA 92649

Phone: [phone] Facsimile: [phone]

Contact Person: Ryan P. Heaney, President

Date Prepared: March 16, 2011

#### Name of Device

H-Wave® (model H4)

#### Common or Usual Name/Classification Name

Powered muscle stimulator 21 C.F.R. § 890.5850 (Product Code IPF)

### Predicate Devices

H-Wave (model P-4), Electronic Waveform Lab, Inc. (K915230)

#### Device Description

The H-Wave® model H4 is a portable battery operated electrical stimulation device with two channels, two sets of lead wires, three packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons to select the desired frequency and a dial to control the intensity of the signal. The stimulator also is supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display. The device creates therapeutic muscle contractions at frequencies of 1-70 Hz depending on the physician instructions and patient settings.

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# Intended Use / Indications for Use

- 1. Relaxation of muscle spasms;
- 2. Prevention or retardation of disuse atrophy;
- 3. Increasing local blood circulation;
- 4. Muscle re-education;
- 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
- 6. Maintaining or increasing range of motion.

# Performance Data

The H-Wave conforms to the following recognized consensus standards:

- IEC 60601-2-10 1987/Amendment 1 2001, Medical electrical equipment Part 2-10: . Particular requirements for the safety of nerve and muscle stimulators.
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; . Amendment 1, 1991-11, Amendment 2, 1995 subclause 56.3(c).
- · IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (2001).

Verification and validation testing of the modifications to the device, including failure analysis of both hardware and software were conducted to ensure that the changes did not affect the safety or effectiveness of the device. In addition, software verification testing was also conducted.

## Substantial Equivalence

| 510(k) Number | | (K915230) |
|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Device Name, Model | H-Wave® (H4) | H-Wave® (P-4) |
| Manufacturer | Electronic Waveform Lab,<br>Inc. | Electronic Waveform Lab,<br>Inc. |
| Power Source | Ni-MH rechargeable<br>battery (7.2 V; 1800 mA/h) | NiCad rechargeable<br>battery (10.8V; 700 mA/h) |
| Line Current Isolation | Yes (battery operated) | Yes (battery operated) |
| Patient Leakage Current | | |
| Normal Condition | 0 | 0 |
| Single fault condition | 0 | 0 |
| Average DC current through<br>electrodes when device is on but no<br>pulses are being applied (µA) | 0 | 0 |
| Frequency | 1-70 Hz | 1-70 Hz |
| Number of output modes | N/A | N/A |
| 510(k) Number | | (K915230) |
| Device Name, Model | H-Wave® (H4) | H-Wave® (P-4) |
| Number of output channels | 2 | 2 |
| synchronous or alternating | alternating | alternating |
| Method of Channel Isolation | galvanic | galvanic |
| Regulated Current or Regulated<br>Voltage | Regulated Voltage | Regulated Voltage |
| Software/firmware/microprocessor | Yes | No |
| Automatic Overload Trip | No | No |
| Automatic No-Load Trip | Yes | No |
| Automatic Shut Off? | No | No |
| Patient Override Control | Yes | Yes |
| Indicator Display | | |
| • On/Off Status | Yes | Yes |
| • Low Battery | Yes | Yes |
| • Voltage/Current Level | Yes | Yes |
| Timer Range (minutes) | 0-60 min. | N/A |
| Compliance with Voluntary Standards | IEC 60601-2-10<br>1987/Amendment 1<br>2001, Medical<br>electrical equipment -<br>Part 2-10: Particular<br>requirements for the<br>safety of nerve and<br>muscle stimulators.<br><br>IEC 60601-1 Medical<br>Electrical Equipment -<br>Part 1: General<br>Requirements for<br>Safety, 1988;<br>Amendment 1,<br>1991-11, Amendment<br>2, 1995 subclause<br>56.3(c)<br><br>IEC 60601-1-2:<br>Medical Electrical<br>Equipment - Part 1-2: | N/A |
| 510(k) Number | | (K915230) |
| Device Name, Model | H-Wave® (H4) | H-Wave® (P-4) |
| | Safety - Collateral<br>Standard:<br>Electromagnetic<br>Compatibility -<br>Requirements and<br>Tests (2001) | |
| Compliance with 21 CFR Part 898 | Yes | Yes |
| Weight | 1.6 lb | 2 lb |
| Dimensions | 7" x 4.5" x 1.5" | 6"x2.34"x6" |
| Housing materials and constructions | ABS plastic housing<br>fastened with screws | ABS plastic housing<br>fastened with screws |

A detailed chart comparing the H-Wave H4 with the predicate H-Wave P-4 is included below:

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The H-Wave® configuration covered by this submission has the same intended uses and output parameters as the original cleared H-Wave. The minor differences in the H-Wave's technological characteristics do not raise any new questions of safety or effectiveness. Thus, the H-Wave model H4 is substantially equivalent to its predicate device.

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Image /page/4/Picture/1 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 health, human services, and prevention. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

Electronic Waveform Lab, Inc. % Mr. Ryan P. Heaney President 16168 Beach Boulevard Suite 232 Huntington Beach, California 92647

JUN - 1 2011

Re: K103738

Trade/Device Name: H - Wave (Model H4) Powered Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: May 6, 2011 Received: May 9, 2011

Dear Mr. Heaney:

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

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## Page 2 - Mr. Ryan P. Heaney

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/CDRH/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,

Euisd Kett

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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## Indications for Use Statement

510(k) Number (if known): __

Device Name: H-Wave®

Indications for Use:

The H-Wave® is indicated for the following conditions:

1. Relaxation of muscle spasms;

2. Prevention or retardation of disuse atrophy;

3. Increasing local blood circulation;

4. Muscle re-education;

5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and

6. Maintaining or increasing range of motion.

Prescription Use × (Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-C (Division Sign-On)
Division of Surgical, Orthopedic,
Division of Surgical, Devices Division of Sirentive Devices

510(k) Number K103738