(106 days)
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.
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.
The provided text describes the 510(k) summary for the HIVOX Electric Stimulator OTC TENS, Rapid ReliefTM Pennypad PP-904. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with acceptance criteria and performance metrics in the way one might expect for a novel AI/medical imaging device.
Therefore, many of the requested sections (sample size, experts, ground truth, MRMC study, training set) are not applicable or cannot be extracted from this type of regulatory submission. The information provided is about an electrical stimulator, not an AI software/imaging device.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical performance study. Instead, it demonstrates performance by comparing its specifications to a predicate device and adhering to recognized electrical safety and performance standards.
| Parameter | Predicate Device (K11-2392) HIVOX | Subject Device (Rapid ReliefTM Pennypad PP-904) |
|---|---|---|
| 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 (differs per model) | Arm, Leg, and Lower Back |
| Dimensions | 113L * 70W * 9.7H mm | (Implicitly similar or identical) |
| Waveform | Symmetrical Biphasic | (Implicitly similar or identical) |
| Shape | Rectangular | (Implicitly similar or identical) |
| Maximum Output Voltage @500Ω | 40.0 Vpp | 57.6 Vpp |
| Maximum Output Current @500Ω | 80.0 mApp | 115.2 mApp |
| Pulse Duration | 200µSec (fixed) | 200µSec (fixed) (from Product Specifications) |
| Frequency | 35 Hz | 2, 5, and 40 Hz (Product Specifications) |
| 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 |
Performance Tests Submitted (Compliance with Standards):
- 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, 2007.
- IEC/EN 60601-2-10: Medical electrical equipment, Part 2-10: Particular requirements for safety of nerve and muscle stimulators, 2001.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a 510(k) summary for an electrical stimulator, not an AI/software device that would typically involve a specific "test set" of data or cases for performance evaluation. The substantial equivalence relies on device specifications and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, for the same reasons as above.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an electrical stimulator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" here is compliance with electrical safety and performance standards for TENS devices, and the established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
Not applicable. There is no AI algorithm being trained.
9. How the ground truth for the training set was established:
Not applicable.
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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'SNAME | 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-MINTEL: 886-2-85112668 FAX:886-3-5209783Email: ceirs.jen@msa.hinet.net |
| • | Date of Submission: | May 23, 2014 |
| • | Trade Name | HIVOX Electric Stimulator OTC TENS, Rapid ReliefTMPennypad PP-904 |
| • | Predicate Devices | K112392HIVOX 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 ReliefTMPennypad PP-904, is indicated for temporary relief of painassociated with sore and aching muscles in the upper and lowerextremities (arm and/or leg), and lower back due to strain fromexercise or normal household and work activities. |
| • | Device Design | The HIVOX Electric Stimulator OTC TENS, Rapid ReliefTMPennypad PP-904, can generate small pulses of electricalcurrent and delivered these pulses pass through the skin andactivated underlying nerves. |
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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.
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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) | HIVOXSubject Device | |
|---|---|---|---|
| Mode or Program Name | PP909PP907PP904 | Rapid ReliefTMPennypad PP-904 | |
| Indication for Applied Area for painrelieve | LowerBackArm andLegLowerBack | Arm, Leg, andLower 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 OutputCurrent(±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 PowerDensity (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".
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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.
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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.
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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
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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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§ 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).