(106 days)
Not Found
No
The summary describes a standard TENS device and does not mention any AI or ML capabilities.
Yes
The device is indicated for "temporary relief of pain associated with sore and aching muscles," which is a therapeutic purpose. It is also referred to as a "Medical electrical equipment" in the performance standards.
No
The device is indicated for temporary pain relief by stimulating nerves and muscles, not for diagnosing medical conditions.
No
The device description explicitly states it "can generate small pulses of electrical current and delivered these pulses pass through the skin and activated underlying nerves," indicating it is a hardware device that delivers electrical stimulation. The performance studies also reference standards for electrical medical equipment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for temporary relief of pain associated with sore and aching muscles. This is a therapeutic use, not a diagnostic one.
- Device Description: The device generates electrical pulses to stimulate nerves. This is a physical therapy modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device interacts directly with the body externally.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The HIVOX Electric Stimulator OTC TENS, Rapid ReliefTM Pennypad PP-904, is indicated for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg), and lower back due to strain from exercise or normal household and work activities.
Product codes
NUH
Device Description
The HIVOX Electric Stimulator OTC TENS, Rapid ReliefTM Pennypad PP-904, can generate small pulses of electrical current and delivered these pulses pass through the skin and activated underlying nerves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower extremities (arm and/or leg), and lower back
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the word "HIVOX" in a bold, sans-serif font. To the right of the word is a symbol that looks like four squares connected to each other. The symbol is slightly smaller than the letters in the word "HIVOX".
5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669
5. 510(k) SUMMARY (According to 21 CFR 807.92)
| • | 510(K) OWNER'S
NAME | HIVOX BIOTEK INC.
5F, No.123, Shingde Road, Sanchong Dist.,
New Taipei City, 24158, TAIWAN, R.O.C.
TEL: +886-2-85112668 FAX:+886-2-85112669 |
|---|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • | Contact Person | Dr. JEN, KE-MIN
TEL: 886-2-85112668 FAX:886-3-5209783
Email: ceirs.jen@msa.hinet.net |
| • | Date of Submission: | May 23, 2014 |
| • | Trade Name | HIVOX Electric Stimulator OTC TENS, Rapid ReliefTM
Pennypad PP-904 |
| • | Predicate Devices | K112392
HIVOX Electric Stimulator OTC TENS, Pennypad 904, 907,
and 909 |
| • | Common Name | Electric Stimulator OTC TENS |
| • | Classification Name | Stimulator, Nerve, Transcutaneous, Over-The-Counter
(21 CFR 890.5890, Product Code NUH) |
| • | Panel | Neurology |
| • | Intended Use | The HIVOX Electric Stimulator OTC TENS, Rapid ReliefTM
Pennypad PP-904, is indicated for temporary relief of pain
associated with sore and aching muscles in the upper and lower
extremities (arm and/or leg), and lower back due to strain from
exercise or normal household and work activities. |
| • | Device Design | The HIVOX Electric Stimulator OTC TENS, Rapid ReliefTM
Pennypad PP-904, can generate small pulses of electrical
current and delivered these pulses pass through the skin and
activated underlying nerves. |
1
Image /page/1/Picture/0 description: The image shows the word "HIVOX" in all caps. To the right of the word is a symbol that looks like a plus sign made of squares. The letters are all the same size and font.
5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669
Product Specifications: Power CR2032 x 1 Pulse rate : 2, 5, and 40Hz (Fixed) Pulse width: 200uS(fixed) Electric impedance of the device: 4.80~5.20 Mohms Output voltage Max. : 57.6 Vp-p, based on 500 Ohm load ± 10% Treatment time: 20 minutes fixed Pulse strength: 0 ~ 15 stages adjustable Operation environment : 10 ~ 40° C, 30 ~ 85% RH Storage environment: -10 ~ 50° C, 10 ~ 95% RH Transport environment: -10 ~ 50° C, 35 ~ 85% RH Size: 113 x 70 x 10 mm
Applicable Electrical Range for the Electrode Pads: Pulse rate: 1150 Hz Pulse strength: 1150 V Pulse width: 100µS ~ 500 mS
· Performance Tests Submitted:
The relevant standards including:
- IEC/EN 60601-1 : Medical electrical equipment Part 1. General 1. requirements for safety, 1996.
-
- IEC/EN 60601-1-2 : Medical electrical equipment, Part 2. Electromagnetic compatibility - Requirements and tests, 2007.
-
- IEC/EN 60601-2-10 : Medical electrical equipment, Part 2-10: Particular requirements for safety of nerve and muscle stimulators, 2001.
2
Image /page/2/Picture/0 description: The image shows the word "HIVOX" in a bold, sans-serif font. To the right of the word is a graphic that looks like four squares arranged in a plus sign shape. The squares are not solid, but rather have a textured or pixelated appearance. The overall impression is of a logo or brand name.
5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669
| Parameter | | HIVOX
(K11-2392) | HIVOX
Subject Device |
|-------------------------------------------------|-------------------------|--------------------------------------------------|-----------------------------------|
| Mode or Program Name | | PP909
PP907
PP904 | Rapid ReliefTM
Pennypad PP-904 |
| Indication for Applied Area for pain
relieve | | Lower
Back
Arm and
Leg
Lower
Back | Arm, Leg, and
Lower Back |
| dimensions | | 113L * 70W * 9.7H mm | |
| Waveform | | Symmetrical Biphasic | |
| Shape | | Rectangular | |
| Maximum Output Voltage
(Volts) (±20%) | @500Ω | 40.0Vpp | 57.6Vpp |
| | @2KΩ | 84.0Vpp | 89.6Vpp |
| | @10KΩ | 92.0Vpp | 96.0Vpp |
| Maximum Output
Current(±20%) | @500Ω | 80.0mApp | 115.2mApp |
| | @2KΩ | 42.0mApp | 44.8mApp |
| | @10KΩ | 9.2mApp | 9.6mApp |
| Duration of primary (depolarizing) phase (µSec) | | NA | |
| Pulse Duration (µSec) | | 200µSec (fixed) | |
| Frequency (Hz) | | 35 | 2, 5, and 40 |
| Net Charge (µC) per pulse | @500Ω | 0.3200 | 0.2304 |
| Maximum Charge (µC) | @500Ω | 16.0 | 23.04 |
| Maximum Current Density
(mA/cm², r.m.s.) | @500Ω | 1.964 | 2.828 |
| Maximum Average Power
Density (W/cm²) | @500Ω | 0.078 | 0.163 |
| Burst Mode | a. Pulse per burst | 1 | NA |
| | b. Burst per second | 4 | NA |
| | c. Burst duration (sec) | 2 | NA |
| | d. Duty Cycle | 8 | NA |
| ON Time(sec) | | 120 | |
| Off Time(sec) | | 0 | |
| Additional Features | | NA | |
Compared to Legally Marketed Predicate Devices
Note: Only the subject device Pennypad 909 has the "Burst Mode".
3
Image /page/3/Picture/0 description: The image shows the word "HIVOX" in bold, black letters. To the right of the "X" is a small graphic of four squares arranged in a plus sign shape. The squares are also black and have a slightly textured appearance.
5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669
DISCUSSION:
The predicate devices, HIVOX Electric Stimulator OTC TENS, Pennypad 904, Pennypad 907, and Pennypad 909, have the same visional appearance, software, and dimensions ( 113 * 70 * 9.7 mm ) as the subject device.
The main differences among the predicated devices are the Indication for Applied Area for pain relieve ..
- Pennypad -904 and Pennypad 909 OTC TENS - Lower Back pain relieve
- · Pennypad 907 OTC TENS Arm and Leg pain relieve
- Only Pennypad 909 has the "Burst Mode". ●
The subject device, HIVOX Electric Stimulator OTC TENS, Rapid Relief 11M Pennypad PP-904, is identical to the predicate devices and only extends the Indication for Applied Area for pain relieve to include the Arm and Leg pain relief.
CONCLUSION:
The subject device, HIVOX Electric Stimulator OTC TENS Rapid Relief ™ Pennypad PP-904, applied for the Arm, Leg, and Lower Back pain relieve is as safe and effective as, and functions in a manner equivalent to the predicate devices. The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the predicate devices.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like symbol with three curved lines representing its wings or feathers. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 27, 2014
HIVOX BIOTEK INC. Dr. Jen. Ke-Min 8F, No. 98, Shingde Road, Sanchong District, Taipei City. Taiwan, ROC
Rc: K140650
Trade/Device Name: Pennypad 904 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: NUH Dated: May 24, 2014 Received: May 30, 2014
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, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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 cither 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 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.
5
Page 2 - Dr. Jen, Ke-Min
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
for
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below
5 10(k) Number (if known)
K140650
Device Name
HIVOX Electric Stimulator OTC TENS, Rapid Relief TN Pennypad PP-904
Indications for Use (Describe)
The Rapid Relief 711 Pennypad PP-904 is indicated for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg), and lower back due to strain from exercise or normal household and work activities.
Type of Use (Select one or both, as applicable)
[[] Prescription Use (Part 21 CFR 801 Subpart D)
0 Over-The-Counter Use (21 CFR 801 Subpan C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
| Felipe | Date: |
|---|---|
| 2014.06.27 | |
| Aguel -S | 16:33:16 -04'00' |
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