Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard electrical stimulation device with manual controls for frequency and intensity. There is no mention of AI, ML, or any adaptive or learning capabilities.

Therapeutic

Yes
The device description and intended use clearly state that it is an electrical stimulation device designed to treat various medical conditions, such as muscle spasms, disuse atrophy, and for muscle re-education, thereby indicating a therapeutic purpose.

Diagnostic

No
The device description and intended use indicate that the H-Wave® is an electrical stimulation device used for therapeutic purposes (e.g., muscle relaxation, re-education, increasing circulation), not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it 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," indicating it is a hardware device with associated software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended uses listed for the H-Wave® are all related to physical therapy and rehabilitation, focusing on muscle function, circulation, and range of motion. These are applications that involve direct interaction with the patient's body and do not involve testing samples of human origin (like blood, urine, or tissue) outside of the body to diagnose or monitor a condition.
Device Description: The device is described as an electrical stimulation device. This type of device delivers electrical impulses to the body for therapeutic purposes, which is characteristic of physical therapy equipment, not IVDs.
Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, detect analytes, or provide diagnostic information based on in vitro testing.

In summary, the H-Wave® is a therapeutic device used for physical rehabilitation, not a device used for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

IPF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

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.

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.

K915230

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

§ 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

0

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: (800) 874-9283 Facsimile: (714) 500-4092

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.

1

Intended Use / Indications for Use

1. Relaxation of muscle spasms;
1. Prevention or retardation of disuse atrophy;
1. Increasing local blood circulation;
1. Muscle re-education;
1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
1. 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,
Inc.	Electronic Waveform Lab,
Inc.
Power Source	Ni-MH rechargeable
battery (7.2 V; 1800 mA/h)	NiCad rechargeable
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
electrodes when device is on but no
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
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
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)

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

2

3

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.

4

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

5

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 (800) 638-2041 or (301) 796-7100 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

6

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:

Relaxation of muscle spasms;
Prevention or retardation of disuse atrophy;
Increasing local blood circulation;
Muscle re-education;
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
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