(232 days)
Not Found
No
The document describes a standard electrical stimulator (TENS/EMS) and does not mention any AI or ML capabilities in its description, intended use, or performance studies.
Yes
The device is indicated for medical purposes such as pain relief, relaxing muscle spasms, and muscle re-education, which are therapeutic applications.
No
Explanation: The device is an electrical nerve and muscle stimulator used for pain relief and muscle conditioning (e.g., relaxing muscle spasms, preventing disuse atrophy). It delivers electrical currents to treat conditions, not to diagnose them.
No
The device description explicitly states that the device "generates small pulses of electrical current. Delivered along lead cables to electrodes placed on your skin". This indicates the presence of hardware components (generator, cables, electrodes) that are integral to the device's function, making it a hardware device with potentially embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an electrical nerve and muscle stimulator for pain relief and muscle treatment by applying electrical currents to the patient's skin. This is a therapeutic use, not a diagnostic one.
- Device Description: The description reinforces that the device generates electrical pulses delivered to the skin to activate nerves. This aligns with the therapeutic function.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples from the body, while this device is used to treat the body directly with electrical stimulation.
N/A
Intended Use / Indications for Use
For TENS programs: The device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief of chronic (long term) intractable pain, and (2) adjunctive treatment in the management of post-surgical and post-traumatic pain problems.
For EMS programs: The device is an electrical powered muscle stimulator indicated for medical purpose to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy.
Product codes (comma separated list FDA assigned to the subject device)
GZJ, IPF
Device Description
The HIVOX Electric Stimulator TENS & EMS, HD2 generates small pulses of electrical current. Delivered along lead cables to electrodes placed on your skin, these pulses pass through the skin and activated underlying nerves. The relief from chronic and acute pain that the HD2 can provide results from this electrical stimulation.
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 relevant standards including:
- IEC/EN 60601-1 : Medical electrical equipment Part 1. General requirements for safety, 1996.
- IEC/EN 60601-1-2 : Medical electrical equipment, Part 2. Electromagnetic compatibility - Requirements and tests, 2004.
- IEC/EN 60601-2-10 : Medical electrical equipment Part 2.Safety of Nerve and Muscle Stimulators, 1987.
Non-Clinical Tests Submitted:
The HIVOX Electric Stimulator TENS & EMS, HD2 has been tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, and the particular requirements for safety of nerve stimulators.
Accessories also meet safety requirements: 510(k) electrodes are specified, and the patient cable utilizes shrouded connectors to meet lead wire safety requirements.
System level testing including waveform testing was performed in combination the HIVOX Electric Stimulator TENS & EMS, HD2.
Clinical Tests Submitted:
None
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
Image /page/0/Picture/0 description: The image contains the word "HIVOX" in a bold, sans-serif font, followed by the registered trademark symbol. To the right of the word is a stylized graphic that resembles a plus sign or cross, composed of interconnected squares or blocks. The graphic has a three-dimensional appearance due to the shading on some of the blocks.
HIVOX BIOTEK INC
8/F, No.98 Shingde Road Sanchong City Taipei 241 Taiwan ROC Fax: +886 2 8511 2669 Phone: +886 2 8511 2668
SUMMARY OF SAFETY AND EFFECTIVENESS for TENS & EMS
510(k): K092448
DATE OF SUBMISSION
i
MAR 3 0 2010
| SUBMISSION: | July 27, 2009 |
|---|---|
| SUBMITTER: | HIVOX BIOTEK INC. |
| 8F, No.98, Shinde Road, | |
| Sanchong City, Taipei, 24158, TAIWAN | |
| TEL: 886-2-85112668 FAX:886-2-85112669 | |
| Email: ceirs.jen@msa.hinet.net |
ESTABLISHMENT REGISTRATION NO: 9611558
OFFICIAL
CONTACT:
Dr. JEN, KE-MIN NO 58, Fu-Chiun Street, Hsin-Chu City, 30067, TAIWAN TEL: 886-3-5208829 FAX:886-3-5209783 Email: ceirs.jen@msa.hinet.net
HIVOX Electric Stimulator TENS & EMS, HD2 TRADE NAME:
COMMON/USUAL Transcutaneous Nerve Stimulator & NAME: Electric Muscle Stimulator
Transcutaneous Nerve Stimulator CLASSIFICATION
NAME:
GZJ, Class II, 882.5890 REGULATION
NUMBER:
ID# Class II 800 59850
SECONDARY PRODUCT CODE: IPF, Class II, 890.5850
PREDICATED DEVICE:
MEDIHIGHTEC Medical Co., Ltd. TENS/EMS Combo, EMS, TENS K082514
1
| HIVOX
| Image: [logo] | HIVOX BIOTEK INC | |
|---|---|---|
| 8/F, No.98 Shingde Road Sanchong City Taipei 241 Taiwan ROC | ||
| Phone: +886 2 8511 2668 Fax: +886 2 8511 2669 | ||
| Intended Use: | For TENS programs: The device is an electrical nerve stimulator | |
| indicated for use for pain relief by applying an electrical current to | ||
| electrodes on a patient's skin to treat pain. In particular, this device | ||
| is indicated for use for (1) Symptomatic relief of chronic (long | ||
| term) intractable pain, and (2) adjunctive treatment in the | ||
| management of post-surgical and post-traumatic pain problems. | ||
| For EMS programs: The device is an electrical powered muscle | ||
| stimulator indicated for medical purpose to repeatedly contract | ||
| muscles by passing electrical currents through electrodes | ||
| contacting the affected body area. In particular, this device is | ||
| indicated for use for (1) Relaxing muscle spasms, (2) Increasing | ||
| local blood circulation, (3) Immediate post-surgical stimulation of | ||
| calf muscles to prevent venous thrombosis, (4) Muscle | ||
| re-education, (5) Maintaining or increasing range of motion, and | ||
| (6) Preventing or retarding disuse atrophy. | ||
| Description of Device: | The HIVOX Electric Stimulator TENS & EMS, HD2 generates | |
| small pulses of electrical current. Delivered along lead cables to | ||
| electrodes placed on your skin, these pulses pass through the skin | ||
| and activated underlying nerves. The relief from chronic and | ||
| acute pain that the HD2 can provide results from this electrical | ||
| stimulation. | ||
| Performance Tests | ||
| Submitted: | The relevant standards including: |
- IEC/EN 60601-1 : Medical electrical equipment Part 1.
General requirements for safety, 1996. - IEC/EN 60601-1-2 : Medical electrical equipment, Part 2.
Electromagnetic compatibility - Requirements and tests, 2004. - IEC/EN 60601-2-10 : Medical electrical equipment Part 2.Safety
of Nerve and Muscle Stimulators, 1987. | |
| Non-Clinical Tests
Submitted: | The HIVOX Electric Stimulator TENS & EMS, HD2 has been
tested in accordance with applicable standards for medical device
electrical safety, electromagnetic compatibility, and the particular
requirements for safety of nerve stimulators.
Accessories also meet safety requirements: 510(k) electrodes are
specified, and the patient cable utilizes shrouded connectors to
meet lead wire safety requirements.
System level testing including waveform testing was performed in
combination the HIVOX Electric Stimulator TENS & EMS, HD2. | |
| Clinical Tests
Submitted: | None | |
| Conclusion: | As the product description and tests as above, the new device:
HIVOX Electric Stimulator TENS & EMS, HD2 is as safe and
effective as, and the function in a manner equivalent to the
predicate device: MEDIHIGHTEC TENS/EMS Combo, EMS,
TENS, K082514. | |
ﺗ
. .
devices in this aspect.
2
HIVOXiff
HIVOX BIOTEK INC
8/F . No.98 Shingde Road Sanchong City Taipei 241 Taiwan ROC Fax: +886 2 8511 2669 Phone: +886 2 8511 2668
Comparison for Predicate Device & Subject Device
| Comparison Areas | NEW DEVICE | PREDICATE DEVICE |
|---|---|---|
| 510(k) number | K092448 | K082514 |
| Manufacturer | HIVOX Biotek Inc | Medihightec Medical Co. Ltd. |
| Device name | HD2 | |
| TENS & EMS | MH8000/6000 | |
| TENS/EMS Combo | ||
| Power source | DC 4.5V | |
| (AAA Battery x 3 ) | One DC 9V battery | |
| Channels | ||
| Synchronous | ||
| Reciprocal | SAME | 2 |
| YES | ||
| YES | ||
| Computerized | SAME | No |
| Software provided | SAME | No |
| Constant current | No | YES |
| Constant voltage | YES | No |
| Max output voltage | ||
| (Vp ±20%) | 24.0V ±20% @ 500 Ω load | 20.4V±20% @500 Ω load |
| (40.8 Vp-p) | ||
| Max output current | ||
| (mA ±20%) | 48.0mA ±20% ( 500 Ω load ) | 40.8 mA±20% ( 500Ω load) |
| (81.6 mA, p-p) | ||
| Pulse Width ( µs ) | 250 µs (fixed) | 50~300 µs |
| Maximum Frequency | 2~120.2 Hz (adjustable) | 2~150 Hz (adjustable) |
| Max phase charge | □12.0 µC @ 500 ohms load | 24.0 µC @ 500 ohm |
| Maximum Current | ||
| Density | 0.59 mA/cm² @500Ω | 1.06 mA/cm² @500Ω |
| Maximum Power | ||
| Density | 0.014 W/cm² @500Ω | 2.4 m W/cm² @500Ω |
| Comparison Areas | NEW DEVICE | PREDICATE DEVICE |
| Channel isolation | SAME | YES |
| Line current isolation | SAME | N/A |
| Patient override | ||
| control method | SAME | YES |
| Burst mode | SAME | YES |
| Housing | ||
| material | ||
| and construction: | SAME | Plastic material |
| Standards: | SAME | IEC 60601-1:1988 |
| EN 60601-1-2:1990 | ||
| Timer setting | ||
| Automatic shut off | SAME | |
| 2 minutes | YES (05~90Min) | |
| 30 Sec | ||
| Automatic overload | ||
| trip current/voltage | ||
| level | N/A | YES |
| Automatic no load trip | N/A | YES |
| Indicator display | ||
| Unit functioning: | Power ON | Power ON, Vpp |
| Low battery | Yes | NO |
| indicator: | ||
| Voltage level: | NO | YES |
| Weight ( unit ) | 105 g w/o Battery | 162 grams w/ battery |
| Dimensions ( unit ) | 120 x 52 x 17 mm | 136 x 70 x 27 mm |
| Size of electrode | Carbon silicon of 45x45 mm | Irregular: 10x15cm |
3
Image /page/3/Picture/1 description: The image shows the word "HIVOX" in all caps, followed by a small superscript symbol and a stylized plus sign. The plus sign is made up of several small squares connected in a winding pattern. The text and symbol are all in black and are set against a white background.
HIVOX BIOTEK INC
8/F, No.98 Shingde Road Sanchong City Taipei 241 Taiwan ROC Phone: +886 2 8511 2668 Fax: +886 2 8511 2669
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Hivox Biotek Inc. c/o Dr. Ke-Min Jen 8F, No. 98, Shinde Rd., Sanchong City Taipei Hsien China (Taiwan) 24158
MAR 3 0 2010
Re: K092448
Trade/Device Name: Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ, IPF Dated: March 12, 2010 Received: March 19, 2010
Dear Dr. Jen:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Dr. Ke-Min Jen
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,
Kevin Alexander
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
510(k) Number:
Device Name:
HIVOX Electric Stimulator TENS & EMS, HD2
Indications for Use :
The TENS programs of HIVOX Electric Stimulator TENS & EMS, HD2:
The device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief of chronic (long term) intractable pain, and (2) adjunctive treatment in the management of post-surgical and post-traumatic pain problems.
The EMS programs of HIVOX Electric Stimulator TENS & EMS, HD2:
The device is an electrical powered muscle stimulator indicated for medical purpose to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy.
Prescription Use _ V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 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-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of 1
510(k) Number K092448