H-WAVE

K112485 · Electronic Waveform Lab, Inc. · GZJ · Dec 6, 2011 · Neurology

Device Facts

• Record ID: K112485
• Device Name: H-WAVE
• Applicant: Electronic Waveform Lab, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Dec 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The H-Wave® H4 is indicated for the treatment of chronic pain, acute pain, postsurgical pain, and temporary pain.

Device Story

H-Wave® H4 is a portable, battery-operated transcutaneous electrical nerve stimulator (TENS) for pain relief. Device features two channels, lead wires, self-adhesive electrodes, and an LCD display. User selects frequency (1-70 Hz) and intensity via buttons and dials. Device delivers regulated voltage stimulation to patient skin. Used in clinical or home settings; operated by patient or clinician. Output provides therapeutic stimulation to manage pain. Device includes automatic no-load trip for safety. Benefits include non-invasive pain management.

Clinical Evidence

Bench testing only. Device conforms to IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC), and IEC 60601-2-10 (Particular requirements for nerve and muscle stimulators). No clinical data provided.

Technological Characteristics

Portable battery-operated (7.2V Ni-MH) TENS device. ABS plastic housing. Two-channel output with galvanic isolation. Regulated voltage stimulation (1-70 Hz). Includes LCD, timer (0-60 min), and automatic no-load trip. Connectivity: None. Sterilization: Not applicable (non-sterile). Software/firmware controlled.

Indications for Use

Indicated for treatment of chronic, acute, post-surgical, and temporary pain in patients requiring transcutaneous electrical nerve stimulation.

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

• Model P, Electronic Waveform Lab, Inc. (K813601)
• Model H-Wave® H4, Electronic Waveform Lab, Inc. (K103738)
• Model HMS DHR-3, Home Medical Services, Inc. (K021496)

Submission Summary (Full Text)

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### 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: October 4, 2011

#### Name of Device

H-Wave® (model H4)

### Common or Usual Name/Classification Name

Transcutaneous Electrical Nerve Stimulator for Pain Relief 21 C.F.R. § 882.5890 (Product Code GZJ)

### Predicate Devices

Model P, Electronic Waveform Lab, Inc. (K813601) Model H-Wave® H4, Electronic Waveform Lab, Inc. (K103738) Model HMS DHR-3, Home Medical Services, Inc. (K021496)

#### Intended Use / Indications for Use

The H-Wave® H4 is indicated for the treatment of chronic pain, acute pain, postsurgical pain, and temporary pain.

#### Technological Characteristics

The H-Wave® model H4 consists of 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 stimulation at frequencies of 1-70 Hz depending on the physician instructions and patient settings.

#### Performance Data

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

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K112485

- 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).

### Substantial Equivalence

A chart comparing the similarities and differences between the H-Wave® H4 and its predicate devices is included below:

| | EWL H-Wave H4<br>(Proposed<br>Device) | EWL P-<br>Tens<br>(K813601) | EWL H-Wave H4<br>(K103738) | Home<br>Medical<br>Services<br>HMS-DHR 3<br>(K021496) | | | |
|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------|--|--|--|
| Frequency | 1-70 Hz | 14-66 Hz | 1-70 Hz | 2-60 Hz<br>(+/- 20%) | | | |
| Power Source | Ni-MH<br>rechargeable<br>battery (7.2 V;<br>1800 mA/h) | Ni-MH<br>rechargeable<br>battery (7.2 V;<br>1800 mA/h) | Ni-MH<br>rechargeable<br>battery (7.2 V;<br>1800 mA/h) | Ni-MH<br>rechargable<br>battery<br>(3.6V) | | | |
| Line Current<br>Isolation | Yes<br>(battery<br>operated) | Yes<br>(battery<br>operated) | Yes<br>(battery<br>operated) | Yes<br>(battery<br>operated) | | | |
| Patient Leakage Current | | | | | | | |
| Normal condition | 0 | 0 | 0 | 0 | | | |
| Single fault<br>condition | 0 | 0 | 0 | 0 | | | |
| Average DC<br>current through<br>electrodes when<br>device is on but no<br>pulses are being<br>applied (µA) | 0 | 0 | 0 | 0 | | | |
| Number of output<br>modes | N/A | N/A | N/A | N/A | | | |
| Number of output<br>channels | 2 | 1 | 2 | 3 | | | |
| Synchronous or<br>alternating | Alternating | Alternating | Alternating | Alternating | | | |
| Method of Channel<br>Isolation | Galvanic | Galvanic | Galvanic | Galvanic | | | |
| Regulated Current<br>or Regulated<br>Voltage | Regulated<br>Voltage | Regulated<br>Voltage | Regulated<br>Voltage | Regulated<br>Voltage | | | |
| Software/firmware/<br>microprocessor | Yes | No | Yes | Yes | | | |
| Automatic<br>Overload Trip | No | No | No | No | | | |

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| | EWL H-Wave H4<br>(Proposed<br>Device) | EWL P-<br>Tens<br>(K813601) | EWL H-Wave H4<br>(K103738) | Home<br>Medical<br>Services<br>HMS-DHR 3<br>(K021496) |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Automatic No-<br>Load Trip | Yes | No | Yes | No |
| Automatic Shut Off | No | No | No | Yes |
| Patient Override<br>Control | Yes | Yes | Yes | Yes |
| Indicator Display | | | | |
| On/Off Status | Yes | Yes | Yes | Yes |
| Low Battery | Yes | Yes | Yes | No |
| Voltage/Current<br>Level | Yes | Yes | Yes | Yes |
| Timer Range<br>(minutes) | 0-60 | N/A | 0-60 | 10-60 (5<br>min<br>intervals) |
| Compliance with<br>Voluntary<br>Standards | IEC 60601-2-<br>10<br>1987/Amendmen<br>t 1 2001, Medical<br>electrical<br>equipment - Part<br>2-10: Particular<br>requirements for<br>the safety of<br>nerve and<br>muscle<br>stimulators<br>IEC 60601-1<br>Medical Electrical<br>Equipment - Part<br>1: General<br>Requirements for<br>Safety, 1988;<br>Amendment 1,<br>1991-11,<br>Amendment 2,<br>1995 subclause<br>56.3(c)<br>IEC 60601-1-2:<br>Medical Electrical<br>Equipment - Part<br>1-2: General<br>Requirements for<br>Safety -<br>Collateral<br>Standard:<br>Electromagnetic | N/A | IEC 60601-2-<br>10<br>1987/Amendment<br>1 2001, Medical<br>electrical<br>equipment - Part<br>2-10: Particular<br>requirements for<br>the safety of<br>nerve and muscle<br>stimulators<br>IEC 60601-1<br>Medical Electrical<br>Equipment - Part<br>1: General<br>Requirements for<br>Safety, 1988;<br>Amendment 1,<br>1991-11,<br>Amendment 2.<br>1995 subclause<br>56.3(c)<br>IEC 60601-1-2:<br>Medical Electrical<br>Equipment - Part<br>1-2: General<br>Requirements for<br>Safety -<br>Collateral<br>Standard:<br>Electromagnetic<br>Compatibility | Unknown |
| | EWL H-Wave H4<br>(Proposed<br>Device) | EWL P-<br>Tens<br>(K813601) | EWL H-Wave H4<br>(K103738) | Home<br>Medical<br>Services<br>HMS-DHR 3<br>(K021496) |
| | Requirements<br>and Tests (2001) | | Requirements<br>and Tests (2001) | |
| Compliance with<br>21CFR Part 898 | Yes | Yes | Yes | Yes |
| Weight | 1.6 lb | 2lb | 1.6 lb | 1lb |
| Dimensions | 7" x 4.5" x 1.5" | 6"x2.34"x6" | 7" x 4.5" x 1.5" | 6.625"Lx4"W<br>x1.75"H |
| Housing materials<br>and constructions | ABS plastic<br>housing fastened<br>with screws | ABS plastic<br>housing<br>fastened<br>with screws | ABS plastic<br>housing fastened<br>with screws | Molded ABS |

\\\DC - 067728/000001 - 3305802 v1

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K112485

The H-Wave® H4 has the same intended uses and substantially similar output parameters as the predicate devices. Specifically, the H-Wave H4 has the same intended uses and substantially similar output parameters as other legally marketed electrical nerve stimulators: the EWL model P (K813601) and the Home Medical Services, Inc. HMS DHR-3 (K021496). In addition, as the H-Wave H4 is technologically identical to the predicate H-Wave® H4 device, the technological characteristics and principles of operation of the H-Wave H4 do not raise any new questions of safety or effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

DEC - 6 2011

Electronic Waveform Lab, Inc. c/o Mr. Ryan P. Heaney President 5702 Bolsa Ave. Huntington Beach, CA 92649

Re: K112485

Trade/Device Name: H-Wave® H4 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: GZJ Dated: October 4, 2011 Received: October 4, 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 10 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, line rec. 1 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.

jr

Sincerely yours,

Malvina B. Eydelman. M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat 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):

K112485

Device Name: H-Wave® H4

Indications for Use:

The H-Wave® H4 is indicated for the treatment of chronic pain, post-surgical pain, and temporary pain.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K112485
510(k) Number

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