(214 days)
The Pennypad 904 and Pennypad 909 are indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
The Pennypad 907 is indicated for Arm & Leg Pain Relief is intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
The HIVOX Electric Stimulator OTC TENS, Pennypad 904, Pennypad 907, and Pennypad 909 can generate small pulses of electrical current. Delivered these pulses pass through the skin and activated underlying nerves.
HIVOX BIOTEK INC. submitted a 510(k) premarket notification (K112392) for their HIVOX Electric Stimulator OTC TENS devices (Pennypad 904, 907, and 909) on July 13, 2011. The submission aimed to demonstrate that these devices are substantially equivalent to previously cleared predicate devices (K060846 and K040512). The FDA cleared the device on March 19, 2012.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are implicitly that the performance of the HIVOX Electric Stimulator OTC TENS devices (Pennypad 904, 907, and 909) must be substantially equivalent to the predicate devices in terms of electrical safety, electromagnetic compatibility, and specific output parameters. The reported performance is a comparison table against two predicate devices. The "reported device performance" is the measured electrical output characteristics of the HIVOX devices.
| Parameter | HIVOX PP909 Performance (Subject Device) | Predicate Device K040512 (2402/2403) Performance | Predicate Device K060846 (T1040) Performance | Acceptance Criteria (Implicit) |
|---|---|---|---|---|
| Waveform | Symmetrical Biphasic | Biphasic | Substantially equivalent (Biphasic and Symmetrical Biphasic are considered equivalent in this context) | |
| Shape | Rectangular | Rectangular | Substantially equivalent (Rectangular) | |
| Maximum Output Voltage (Vpp) @500Ω | 40.0Vpp | 57.6Vpp | 40.7V | Within acceptable range compared to predicate devices |
| Maximum Output Voltage (Vpp) @2KΩ | 84.0Vpp | 89.6Vpp | 105.1V | Within acceptable range compared to predicate devices |
| Maximum Output Voltage (Vpp) @10KΩ | 92.0Vpp | 96.0Vpp | 154.1V | Within acceptable range compared to predicate devices |
| Maximum Output Current (mApp) @500Ω | 80.0mApp | 115.2mApp | 81.4mA | Within acceptable range compared to predicate devices |
| Maximum Output Current (mApp) @2KΩ | 42.0mApp | 44.8mApp | 47.8mA | Within acceptable range compared to predicate devices |
| Maximum Output Current (mApp) @10KΩ | 9.2mApp | 9.6mApp | 15.4mA | Within acceptable range compared to predicate devices |
| Pulse Duration (µSec) | 200µSec (fixed) | 250 µSec | 4.1~500mS | Within acceptable range compared to predicate devices (fixed vs variable but similar order of magnitude) |
| Frequency (Hz) | 35 | 2, 5, and 40 | 245Hz | Within acceptable range compared to predicate devices |
| Net Charge (µC) per pulse @500Ω | 0.3200 | 0.2304 | 4.07 | Within acceptable range compared to predicate devices |
| Maximum Charge (µC) @500Ω | 16.0 | 23.04 | 16.9 | Within acceptable range compared to predicate devices |
| Maximum Current Density (mA/cm², r.m.s.) @500Ω | 1.964 | 2.828 | 2.71 | Within acceptable range compared to predicate devices |
| Maximum Average Power Density (W/cm²) @500Ω | 0.078 | 0.163 | 5.35mW/cm² | Within acceptable range compared to predicate devices |
| Burst Mode (PP909 only): | Not Available | Not Available | Acceptable as an additional feature, not present in all predicates, but within safety limits. | |
| a. Pulse per burst | 1 | NA | NA | |
| b. Burst per second | 4 | NA | NA | |
| c. Burst duration (sec) | 2 | NA | NA | |
| d. Duty Cycle | 8 | NA | NA | |
| ON Time (sec) | 120 | NA | NA | Within acceptable limits for TENS devices |
| Off Time (sec) | 0 | NA | NA | Within acceptable limits for TENS devices |
| HIVOX PP907 Performance (Subject Device) | ||||
| Maximum Output Voltage (Vpp) @500Ω | 68.8V | 40.7V rms | Within acceptable range compared to predicate devices | |
| Maximum Output Voltage (Vpp) @2KΩ | 88.0V | 105.1 V rms | Within acceptable range compared to predicate devices | |
| Maximum Output Voltage (Vpp) @10KΩ | 95.2V | 154.1V rms | Within acceptable range compared to predicate devices | |
| Maximum Output Current (mApp) @500Ω | 137.6mA | 81.4mA rms | Within acceptable range compared to predicate devices | |
| Maximum Output Current (mApp) @2KΩ | 44.0mA | 47.8mA rms | Within acceptable range compared to predicate devices | |
| Maximum Output Current (mApp) @10KΩ | 9.52mA | 15.4mArms | Within acceptable range compared to predicate devices | |
| Pulse Duration (µSec) | 200µSec (fixed) | 4.1~500mS | Within acceptable range compared to predicate devices | |
| Frequency (Hz) | 2 and 40 | 245Hz | Within acceptable range compared to predicate devices | |
| Net Charge (µC) per pulse @500Ω | 1.1008 | 4.07 | Within acceptable range compared to predicate devices | |
| Maximum Charge (µC) @500Ω | 27.52 | 16.9 | Within acceptable range compared to predicate devices | |
| Maximum Current Density (mA/cm², r.m.s.) @500Ω | 3.378 | 2.71 | Within acceptable range compared to predicate devices | |
| Maximum Average Power Density (W/cm²) @500Ω | 0.232 | 5.35mW/cm² | Within acceptable range compared to predicate devices |
Study to prove device meets acceptance criteria:
The study proving the device meets the acceptance criteria is a non-clinical performance testing and substantial equivalence comparison against legally marketed predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not applicable in the context of this 510(k) submission. The testing conducted was electrical safety and performance testing on the device itself, rather than a clinical study with a patient test set.
- Data provenance: The testing was performed in accordance with international standards, implying compliance with established methodologies for medical device electrical safety and electromagnetic compatibility. The submitter, HIVOX BIOTEK INC., is based in New Taipei City, Taiwan, R.O.C., which is the country of origin of the device and likely where the non-clinical testing was conducted. The data is prospective, in that it was generated for the purpose of this submission.
- Retrospective or prospective: Prospective (tests were specifically conducted for the purpose of this 510(k) submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable. This was a non-clinical device performance and safety testing submission, not a study requiring expert readers to establish ground truth for a test set of medical cases.
- Qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. There was no clinical test set requiring adjudication.
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
- MRMC study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a TENS unit, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: Not applicable. This is a physical medical device (TENS unit), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: The "ground truth" in this context refers to established international consensus standards for electrical safety (IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-2-10) and the electrical output specifications of the predicate devices. The HIVOX devices' measured electrical parameters were compared against these standards and the predicate device specifications to demonstrate substantial equivalence.
8. The sample size for the training set
- Sample size for the training set: Not applicable. There is no AI component or machine learning involved that would require a training set.
9. How the ground truth for the training set was established
- How ground truth for training set was established: Not applicable, as there was no training set.
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HIVOX BIOTEK INC.
5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan . Phone: +886 2 8511 2668 Fax: +886 2 8511 2669
SUMMARY OF SAFETY AND EFFECTIVENESS for HIVOX Electric Stimulator OTC TENS
HIVO>
MAR 1 9 2012
510(k): K112392
| DATE OF | |
|---|---|
| SUBMISSION: | July 13, 2011 |
| SUBMITTER: | HIVOX BIOTEK INC. |
| 5F, No.123, Shinde Road, Sanchong Dist.,New Taipei City, 24158, TAIWAN, R.O.C.TEL: 886-2-85112668 FAX:886-2-85112669 | |
| ESTABLISHMENTREGISTRATION NO: | 9611558 |
| OFFICIALCONTACT: | Dr. JEN, KE-MINTEL: 886-2-85112668 FAX:886-3-5209783Email: ceirs.jen@msa.hinet.net |
| TRADE NAME: | HIVOX Electric Stimulator OTC TENSPennypad 904 and Pennypad 909 : OTC TENS - LowerBack pain relievePennypad 907: OTC TENS - Arm and Leg pain relief |
| COMMON/USUALNAME: | Stimulator, Nerve, Transcutaneous,Over-The-Counter |
| CLASSIFICATIONNAME: | Transcutaneous Nerve Stimulator |
| REGULATIONNUMBER: | NUH, Class II, 882.5890 |
| SECONDARYPRODUCT CODE: | GZJ, Class II, 882.5890 |
| PREDICATEDDEVICE: | Therapeutic Massage Companion, Endurance Therapeutics1) K060846, OTC TENS for Lower Back, Arm and LegPain Relief, T1040WELL-LIFE Healthcare Limited2) K040512, Limited Function OTC TENS, for LowerBack Pain Relief, WL-2402, WL-2403 |
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Image /page/1/Picture/0 description: The image shows the word "HIVOX" in bold, sans-serif font. To the right of the word is a symbol that looks like a plus sign made of squares. The symbol is also in bold and has a similar line thickness to the letters.
ﻪ ﻣﺮ
HIVOX BIOTEK INC.
5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669
| Intended Use: | The HIVOX Electric Stimulator OTC TENS, Pennypad 904 andPennypad 909 are indicated for temporary relief of pain associatedwith sore and aching muscles in the lower back due to strain fromexercise or normal household and work activities.The HIVOX Electric Stimulator OTC TENS, Pennypad 907 isindicated for Arm & Leg Pain Relief is intended for temporaryrelief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. |
|---|---|
| Description of Device: | The HIVOX Electric Stimulator OTC TENS, Pennypad 904,Pennypad 907, and Pennypad 909 can generate small pulses ofelectrical current. Delivered these pulses pass through the skin and activated underlying nerves. |
| Performance TestsSubmitted: | The relevant standards including:1. IEC/EN 60601-1 : Medical electrical equipment Part 1.General requirements for safety, 1996.2. IEC/EN 60601-1-2 : Medical electrical equipment, Part 2.Electromagnetic compatibility - Requirements and tests, 2007.3. IEC/EN 60601-2-10 : Medical electrical equipment, Part 2-10:Particular requirements for safety of nerve and musclestimulators, 2001. |
| Non-Clinical TestsSubmitted: | The HIVOX Electric Stimulator OTC TENS, Pennypad 904,Pennypad 907, and Pennypad 909 have been tested in accordancewith applicable standards for medical device electrical safety,electromagnetic compatibility, and the particular requirements for Accessories also meet safety requirements: 510(k) electrodes arespecified the safety requirements.System level testing including waveform testing was performed in combination the HIVOX Electric Stimulator OTC TENS. |
| Clinical TestsSubmitted: | None |
| Conclusion: | As the product description and tests as above, the new devices:HIVOX Electric Stimulator OTC TENS, Pennypad 904, Pennypad907, and Pennypad 909 are as safe and effective as, and thefunction in a manner equivalent to the predicate devices: K060846,OTC TENS for Lower Back, Arm and Leg Pain Relief, T1040; andK040512, Limited Function OTC TENS, for Lower Back PainRelief, WL-2402, WL-2403.Thus the new device is substantially equivalent to the predicate devices in this aspect. |
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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 "X" is a small, stylized graphic that resembles a plus sign made up of small squares. The letters are uniformly black, providing a stark contrast against the white background.
HIVOX BIOTEK INC.
5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 - Fax: +886 2 8511 2669
Comparison for Predicate Device & Subject Device
● COMPARISON TABLE 1
We present the relevant information for the predicate device here for demonstrating the characteristics of the predicate device.
| Parameter | HIVOX | Well Life(K)040512. | EnduranceTherapeutics(K)060846. | |||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mode or Program Name | PP909 | PP904 | 2402/2403 | T1040 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Waveform | Symmetrical Biphasic | Biphasic | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Shape | Rectangular | Rectangular | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Maximum Output Voltage(Volts) (±20%) | @500Ω | 40.0Vpp | 57.6Vpp | 38.2V rms | 40.7V | |||||||||||||||||||||||||||||||||||||||||||||||
| @2KΩ | 84.0Vpp | 89.6Vpp | 52.8V rms | 105.1V | ||||||||||||||||||||||||||||||||||||||||||||||||
| @10KΩ | 92.0Vpp | 96.0Vpp | 84.8V rms | 154.1V | ||||||||||||||||||||||||||||||||||||||||||||||||
| Maximum OutputCurrent(±20%) | @500Ω | 80.0mApp | 115.2mApp | 76.2mA rms | 81.4mA | |||||||||||||||||||||||||||||||||||||||||||||||
| @2KΩ | 42.0mApp | 44.8mApp | 52.8mA rms | 47.8mA | ||||||||||||||||||||||||||||||||||||||||||||||||
| @10KΩ | 9.2mApp | 9.6mApp | 8.48mA rms | 15.4mA | ||||||||||||||||||||||||||||||||||||||||||||||||
| Duration of primary (depolarizing)phase (µSec) | NA | NA | NA | |||||||||||||||||||||||||||||||||||||||||||||||||
| Pulse Duration (µSec) | 200µSec (fixed) | 250 µSec | 4.1~500mS | |||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency (Hz) | 35 | 2, 5, and 40 | 25Hz | 245Hz | ||||||||||||||||||||||||||||||||||||||||||||||||
| Net Charge (µC)per pulse | @500Ω | 0.3200 | 0.2304 | 16.0/8.76 | 4.07 | |||||||||||||||||||||||||||||||||||||||||||||||
| Maximum Charge (µC) | @500Ω | 16.0 | 23.04 | 12.5/9.2 | 16.9 | Maximum Current Density(mA/cm², r.m.s.) | @500Ω | 1.964 | 2.828 | 0.006 | 2.71 | Maximum Average PowerDensity (W/cm²) | @500Ω | 0.078 | 0.163 | 0.000848/0.002292 | 5.35(mW/cm²) | Burst Mode | a. Pulse per burst | 1 | NA | NA | NA | b. Burst per second | 4 | NA | NA | NA | c. Burst duration (sec) | 2 | NA | NA | NA | d. Duty Cycle | 8 | NA | NA | NA | ON Time(sec) | 120 | NA | NA | Off Time(sec) | 0 | NA | NA | Additional Features | NA | ||||
| Maximum Charge (µC) | @500Ω | 16.0 | 23.04 | 12.5/9.2 | 16.9 | |||||||||||||||||||||||||||||||||||||||||||||||
| Maximum Current Density(mA/cm², r.m.s.) | @500Ω | 1.964 | 2.828 | 0.006 | 2.71 | |||||||||||||||||||||||||||||||||||||||||||||||
| Maximum Average PowerDensity (W/cm²) | @500Ω | 0.078 | 0.163 | 0.000848/0.002292 | 5.35(mW/cm²) | |||||||||||||||||||||||||||||||||||||||||||||||
| Burst Mode | a. Pulse per burst | 1 | NA | NA | NA | b. Burst per second | 4 | NA | NA | NA | c. Burst duration (sec) | 2 | NA | NA | NA | d. Duty Cycle | 8 | NA | NA | NA | ON Time(sec) | 120 | NA | NA | Off Time(sec) | 0 | NA | NA | Additional Features | NA | NA | NA | ||||||||||||||||||||
| Burst Mode | a. Pulse per burst | 1 | NA | NA | NA | |||||||||||||||||||||||||||||||||||||||||||||||
| b. Burst per second | 4 | NA | NA | NA | ||||||||||||||||||||||||||||||||||||||||||||||||
| c. Burst duration (sec) | 2 | NA | NA | NA | ||||||||||||||||||||||||||||||||||||||||||||||||
| d. Duty Cycle | 8 | NA | NA | NA | ||||||||||||||||||||||||||||||||||||||||||||||||
| ON Time(sec) | 120 | NA | NA | |||||||||||||||||||||||||||||||||||||||||||||||||
| Off Time(sec) | 0 | NA | NA | |||||||||||||||||||||||||||||||||||||||||||||||||
| Additional Features | NA | NA | NA |
Note: The subject device only Pennypad 909 has the "Burst Mode".
Formula
inula
Current Density – ((Max Voltage@500ohm)x1000)/electrode area (40.732cm²)
Power Density – (Amp x V)/ Electrode Area(40.732cm²)
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Image /page/3/Picture/0 description: The image shows a blurry, black and white close-up of what appears to be a small object or mark. The object is positioned off-center, with some indistinct features. Due to the lack of clarity, it is difficult to determine the exact nature or context of the image.
HIV
HIVOX BIOTEK INC.
5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669
● COMPARISON TABLE 2
We present the relevant information for the predicate device here for demonstrating the characteristics of the predicate device.
| Parameter | HIVOX | EnduranceTherapeutics(K)060846 | |
|---|---|---|---|
| Mode or Program Name | PP907 | T1040 | |
| Waveform | SymmetricalBiphasic | Biphasic | |
| Shape | Rectangular | Rectangular | |
| Maximum Output Voltage (Volts) (±20%)Peak to peak | @500Ω | 68.8V | 40.7V rms |
| @2KΩ | 88.0V | 105.1 V rms | |
| @10KΩ | 95.2V | 154.1V rms | |
| Maximum Output Current(±20%)Peak to peak | @500Ω | 137.6mA | 81.4mA rms |
| @2KΩ | 44.0mA | 47.8mA rms | |
| @10KΩ | 9.52mA | 15.4mArms | |
| Duration of primary (depolarizing) phase (µSec) | NA | NA | |
| Pulse Duration (µSec) | 200µSec (fixed) | 4.1~500mS | |
| Frequency (Hz) | 2 and 40 | 245Hz | |
| Net Charge (µC) per pulse | @500Ω | 1.1008 | 4.07 |
| Maximum Charge (µC) | @500Ω | 27.52 | 16.9 |
| Maximum Current Density(mA/cm², r.m.s.) | @500Ω | 3.378 | 2.71 |
| Maximum Average Power Density(W/cm²) | @500Ω | 0.232 | 5.35(mW/cm²) |
| Burst Mode | a. Pulse per burst | NA | NA |
| b. Burst per second | NA | NA | |
| c. Burst duration (sec) | NA | NA | |
| d. Duty Cycle | NA | NA | |
| ON Time(sec) | 120 | NA | |
| Off Time(sec) | 0 | NA | |
| Additional Features | NA | NA |
Formula:
r critical
Current Density – ((Max Voltage(@500ohm)x1000)/electrode area (40.732cm²) Power Density - (Amp x V)/ Electrode Area(40.732cm2)
{4}------------------------------------------------
5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669
DISCUSSION:
・・
The 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 ) the main difference is:
- Pennypad 904 and Pennypad 909 : OTC TENS Lower Back pain relieve ●
- Pennypad 907: OTC TENS Arm and Leg pain relief ●
- Only Pennypad 909 has the "Burst Mode".
As the product description and tests as above, the new devices: HIVOX Electric Stimulator OTC TENS, Pennypad 904, Pennypad 907, and Pennypad 909 are as safe and effective as, and the function in a manner equivalent to the predicate devices: K060846, OTC TENS for Lower Back, Arm and Leg Pain Relief, T1040; and K040512, Limited Function OTC TENS, for Lower Back Pain Relief, WL-2402, WL-2403.. Thus the new devices are substantially equivalent to the predicate devices in this aspect.
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Image /page/5/Picture/1 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 figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
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 Official Correspondent 5F., No. 123, Shinde Road Sanchong District New Taipei City China, Taiwan 24158
MAR 1 9 2012
Re: K112392
Trade/Device Name: HIVOX Electric Stimulator OTC TENS Models: Pennypad 904, 909 -- Lower back pain relief Pennypad 907 - Arm and Leg pain relief Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH Dated: February 24, 2012 Received: March 8, 2012
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 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 fray of our of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Ke-Min Jen
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.
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/CDRHQffices/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kesia Alexander
$\fn$
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
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Indications for Use
510(k) Number:
KII2392
Device Name:
HIVOX Electric Stimulator OTC TENS Pennypad 904, 909 : OTC TENS – Lower back pain relieve Pennypad 907: OTC TENS – Arm and Leg pain relief
Indications for Use :
The Pennypad 904 and Pennypad 909 are indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
The Pennypad 907 is indicated for Arm & Leg Pain Relief is intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
Prescription Use _____________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ V (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 1K112392
< 1 ( V ) Number
§ 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).