(99 days)
Not Found
No
The device description and performance studies focus on standard electrical stimulation technology and compliance with electrical safety standards. There is no mention of AI, ML, or any related concepts in the provided text.
Yes
The device is indicated for the treatment of various types of pain (chronic, acute, postsurgical, temporary), which is a clear therapeutic use.
No
The device is described as an electrical stimulation device for treating pain, not for diagnosing conditions. Its function is therapeutic, not diagnostic.
No
The device description explicitly states it consists of hardware components including a portable battery operated electrical stimulation device, lead wires, electrodes, a battery charger, buttons, dials, output jacks, a charging jack, timer buttons, and an LCD display.
Based on the provided information, the H-Wave® H4 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of pain (chronic, acute, postsurgical, and temporary). This is a therapeutic use, not a diagnostic one.
- Device Description: The device is an electrical stimulator that applies electrical signals to the body. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in a lab setting, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The H-Wave® H4's function is to directly treat pain through electrical stimulation.
N/A
Intended Use / Indications for Use
The H-Wave® H4 is indicated for the treatment of chronic pain, acute pain, postsurgical pain, and temporary pain.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
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.
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)
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).
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.
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
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).
0
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: 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:
1
- 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
(Proposed
Device) | EWL P-
Tens
(K813601) | EWL H-Wave H4
(K103738) | Home
Medical
Services
HMS-DHR 3
(K021496) | | | |
|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------|--|--|--|
| Frequency | 1-70 Hz | 14-66 Hz | 1-70 Hz | 2-60 Hz
(+/- 20%) | | | |
| Power Source | Ni-MH
rechargeable
battery (7.2 V;
1800 mA/h) | Ni-MH
rechargeable
battery (7.2 V;
1800 mA/h) | Ni-MH
rechargeable
battery (7.2 V;
1800 mA/h) | Ni-MH
rechargable
battery
(3.6V) | | | |
| Line Current
Isolation | Yes
(battery
operated) | Yes
(battery
operated) | Yes
(battery
operated) | Yes
(battery
operated) | | | |
| Patient Leakage Current | | | | | | | |
| Normal condition | 0 | 0 | 0 | 0 | | | |
| Single fault
condition | 0 | 0 | 0 | 0 | | | |
| Average DC
current through
electrodes when
device is on but no
pulses are being
applied (µA) | 0 | 0 | 0 | 0 | | | |
| Number of output
modes | N/A | N/A | N/A | N/A | | | |
| Number of output
channels | 2 | 1 | 2 | 3 | | | |
| Synchronous or
alternating | Alternating | Alternating | Alternating | Alternating | | | |
| Method of Channel
Isolation | Galvanic | Galvanic | Galvanic | Galvanic | | | |
| Regulated Current
or Regulated
Voltage | Regulated
Voltage | Regulated
Voltage | Regulated
Voltage | Regulated
Voltage | | | |
| Software/firmware/
microprocessor | Yes | No | Yes | Yes | | | |
| Automatic
Overload Trip | No | No | No | No | | | |
2
| | EWL H-Wave H4
(Proposed
Device) | EWL P-
Tens
(K813601) | EWL H-Wave H4
(K103738) | Home
Medical
Services
HMS-DHR 3
(K021496) |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Automatic No-
Load Trip | Yes | No | Yes | No |
| Automatic Shut Off | No | No | No | Yes |
| Patient Override
Control | Yes | Yes | Yes | Yes |
| Indicator Display | | | | |
| On/Off Status | Yes | Yes | Yes | Yes |
| Low Battery | Yes | Yes | Yes | No |
| Voltage/Current
Level | Yes | Yes | Yes | Yes |
| Timer Range
(minutes) | 0-60 | N/A | 0-60 | 10-60 (5
min
intervals) |
| Compliance with
Voluntary
Standards | IEC 60601-2-
10
1987/Amendmen
t 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 | N/A | 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 | Unknown |
| | EWL H-Wave H4
(Proposed
Device) | EWL P-
Tens
(K813601) | EWL H-Wave H4
(K103738) | Home
Medical
Services
HMS-DHR 3
(K021496) |
| | Requirements
and Tests (2001) | | Requirements
and Tests (2001) | |
| Compliance with
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
x1.75"H |
| Housing materials
and constructions | ABS plastic
housing fastened
with screws | ABS plastic
housing
fastened
with screws | ABS plastic
housing fastened
with screws | Molded ABS |
\\DC - 067728/000001 - 3305802 v1
3
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.
4
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
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.
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
6
Indications for Use Statement
510(k) Number (if known):
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)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
[K112485](https://510k.innolitics.com/search/K112485)
510(k) Number
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