(145 days)
Not Found
No
The description details a standard TENS device with preset programs and adjustable intensity, with no mention of AI or ML capabilities.
Yes.
The device is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain, which are therapeutic indications.
No
Explanation: The device description states it is a TENS device used for "symptomatic relief and management of chronic intractable pain," and it generates electrical pulses for pain blocking. This indicates a therapeutic, rather than a diagnostic, purpose.
No
The device description explicitly states it is a "handheld battery powered TENS device" that generates electrical pulses and transmits them to electrodes. This indicates a physical hardware component responsible for delivering the therapy, not solely software.
Based on the provided information, the LL TENS 160A and LL TENS 160B devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use is for "symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain." This describes a therapeutic application, not a diagnostic one.
- Device Description: The device description explains that it generates electrical pulses transmitted to electrodes on the skin to block pain signals. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
In summary, the LL TENS 160A and LL TENS 160B are therapeutic devices used for pain management, not diagnostic devices used for testing biological samples.
N/A
Intended Use / Indications for Use
The LL TENS 160A and LL TENS 160B are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
LL TENS 160A and LL TENS 160B are handheld battery powered TENS devices for pain relief intended for over-the-counter use. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's (user's) skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.
LL TENS 160A and LL TENS 160B has two output channels and four preset programs. The program mode is displayed on LCD. The user can adjust the output intensity by 14 steps.
LL TENS 160A and LL TENS 160B have same hardware, software and mechanical structure. The difference is that LL TENS 160A's LCD display is placed on the bottom of keys while LL TENS 160B's LCD display is on the top of keys.
Since the device is battery powered, there is no connection to AC mains supply.
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
Adult
Intended User / Care Setting
Clinics, hospital and home environment
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)
Study Type: Usability study
Sample Size: Not Found
Key Results: A usability study has been performed and showed that users were able to use the device correctly and safety.
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other, representing the human element of the department's work.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2016
Fuji Dynamics Ltd Man Man Chung Unit 1-3, 23/F., Laws Commercial Plaza 788 Cheung Sha Wan Road, Kowloon Hong Kong
Re: K152374
Trade/Device Name: LL TENS 160A, LL TENS 160B Regulation Number: 21 CFR 882.5890 Regulation Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Regulatory Class: Class II Product Code: NUH Dated: December 8, 2015 Received: December 11, 2015
Dear Man Man Chung:
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 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
1
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 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/Resourcesfor You/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,
William J.Heetderks -S
for Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152374
Device Name
LL TENS 160A LL TENS 160B
Indications for Use (Describe)
The LL TENS 160A and LL TENS 160B are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Type of Use (Select one or both, as applicable):
| Experimental Use (Applicable if an IDE with a Pediatric Extrapolation Plan) | |
|---|---|
| Compassionate Use (Applicable if an IDE with a Pediatric Extrapolation Plan) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Date of submission prepared: 24 December 2015
| Submitter: | Fuji Dynamics Ltd. | |
|---|---|---|
| Address : | Unit 1-3, 23/F., Laws Commercial Plaza | |
| 788 Cheung Sha Wan Road, Kowloon, Hong Kong | ||
| Tel : | (852) 2786 4218 | |
| Fax : | (852) 2744 6775 | |
| E-Mail : | fdman@fuji-dynamics.com.hk | |
| Official Contact: | Man, Man Chung | |
| Address of the manufacturing facility : | No. A46, Gao Er South Road, | |
| Pin Shan, Tangxia Town, | ||
| Dong Guan City, | ||
| Guang Dong Province, China | ||
| SUBMITTED DEVICE : | ||
| Generic Name: | Transcutaneous Electrical Nerve Stimulator | |
| (T.E.N.S) | ||
| Proprietary or Trade Name: | LL TENS 160A | |
| LL TENS 160B | ||
| Common / Usual Name: | Stimulator, nerve, transcutaneous, over-the counter | |
| Classification Name: | Stimulator, nerve, transcutaneous, over-the counter | |
| 21 CFR 882.5890 | ||
| Product Code: | NUH | |
| Device Panel: | Neurology | |
| Device Classification: | Class II |
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PREDICATE DEVICES :
Device Name: Pain Buddy Applicant: Biomedical Life Systems. Inc. 510(k) Number: K102051 Product Code: NUH
INDICATIONS FOR USE :
LL TENS 160A and LL TENS 160B are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
DEVICE DESCRIPTION :
LL TENS 160A and LL TENS 160B are handheld battery powered TENS devices for pain relief intended for over-the-counter use. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's (user's) skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.
LL TENS 160A and LL TENS 160B has two output channels and four preset programs. The program mode is displayed on LCD. The user can adjust the output intensity by 14 steps.
LL TENS 160A and LL TENS 160B have same hardware, software and mechanical structure. The difference is that LL TENS 160A's LCD display is placed on the bottom of keys while LL TENS 160B's LCD display is on the top of keys.
Since the device is battery powered, there is no connection to AC mains supply.
5
SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Attribute | Applicant Device | Predicate Device |
|---|---|---|
| Product Name | LL TENS 160A | |
| LL TENS 160B | Pain Buddy | |
| 510(K) number | K152374 | K102051 |
| Product Code | NUH | NUH |
| Indications for use | This device is used for the | |
| symptomatic relief and | ||
| management of chronic intractable | ||
| pain and/or as an adjunctive | ||
| treatment in the management of | ||
| post-surgical and post-traumatic | ||
| acute pain. | Same as applicant device | |
| Patient Population | Adult | Adult |
| Prescriptive or OTC | OTC | OTC |
| Environment of use | Clinics, hospital and home | |
| environment | Clinics, hospital and home | |
| environment | ||
| Number of output | ||
| modes | 4 | 1 |
| Number of output | ||
| channels | 2 | 1 |
| Waveform | Alternating Bi-phasic symmetrical | |
| Rectangular waveform | Asymmetrical Biphasic | |
| Rectangular waveform | ||
| Maximum output | ||
| Voltage (max) | ||
| 500 Ω | 70V | 30V |
| 2K Ω | 98V | 36.8V |
| 10K Ω | 108V | 38.4V |
| Maximum output | ||
| Current (max) | ||
| 500 Ω | 140 mA | 60 mA |
| 2K Ω | 49 mA | 18.4 mA |
| 10K Ω | 10.8 mA | 3.84 mA |
| Maximum Phase | ||
| charge (500 Ω) | 18.1 μC | 13.3 μC |
| Maximum Average | ||
| Current (500 Ω) | 0.9 mA | 0.2 mA |
| Maximum Current | ||
| density (500 Ω) | 0.062 mA/cm² | 0.066 mA |
| Maximum Power | ||
| Density (500 Ω) | 2.25 mW/cm² | 2.28 mW / cm² |
| Frequency (Hz) | 90 Hz | 80 Hz |
| Pulse Duration (μs) | 208 μs | 160 μs |
| Burst Mode | Yes | No |
| Timer range (min) | Continuous, 15 min, 30 min, 45 min | |
| and 60 min selectable. | Continuous | |
| Indication display | ||
| -On/Off status | Yes | Yes |
| -Low Battery | Yes | Yes |
| -Voltage/Current level | Yes | Yes |
| -Output mode | Yes | Yes |
| -Time to cut-off | No | No |
| Power Source | 2 AAA Batteries | 2 AAA Batteries |
| Dimensions (mm) | 38 (W) x 127 (L) x 20 (H) mm | 35 (W) x 125(L) x 16(H) mm |
| Weight | 70 g | 60 g |
| Housing material | ABS | ABS |
| Microprocessor control | Yes | Yes |
| Automatic Overload | ||
| trip | No | No |
| Automatic no-load trip | Yes | Yes |
| Automatic shut-off | Yes | Yes |
| Electrode compliance | ||
| with 21 CFR 898 | Yes | Yes |
| Electrode cable | Yes | Yes |
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E. 510(k) Summary
7
DIFFERENCES BETWEEN NEW DEVICE AND PREDICATE DEVICE:
The technical characteristics of LL TENS 160A / LL TENS 160B are similar to those of the predicate devices in design, energy source, intended use and function. Like the predicate device Pain Buddy, the LL TENS 160A / LL TENS 160B is a device used to apply an electrical current to electrodes on a patient's skin to relieve pain.
LL TENS 160A and LL TENS 160B are developed on the similar platform as the predicate device Pain Buddy. On hardware, the schematic and the use of electronics components are similar. The software uses same mechanism as Pain Buddy. Therefore the basic timing, key scanning and generation of pulse are the same.
Some output parameters, including maximum output voltage, maximum output current, phase charge, maximum average current, maximum frequency and pulse duration are different from those of Pain Buddy. However, the maximum phase charge of LL TENS is 18.1uC, which is less than the limit of the safety standard. The Maximum average current is 0.9mA, which is also below the 10mA limit. The maximum average power density is 0.0025 W/cm², which is also less than 0.25W/cm². The maximum frequency of LL TENS is 90Hz. It is slightly higher than those of predicate device and thus does not raise question of safety and effectiveness. Finally, the maximum pulse duration is 208us and higher than of predicate device. Nevertheless, the maximum phase charge of LL TENS is still less than safety limit in this pulse duration. In conclusion, these differences between LL TENS and predicate device do not raise a question in safety and effectiveness.
The LL TENS 160A and LL TENS 160B are views as substantially equivalent to the predicate devices because the electrical stimulation provided by the LL TENS 160A and LL TENS 160B is substantially equivalent to that commonly employed by TENS devices that have been cleared for marketing without prescription labeling, i.e. for OTC use.
The differences between LL TENS and the predicate device do not raise questions on safety and effectiveness. In other word, LL TENS 160A and LL TENS 160B are as safe as the predicate device.
PERFORMANCE TESTS:
The relevant standards including :
IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance.
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IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic Compatibility. (Edition 3).
IEC 60601-1-11:2010 Medical electrical equipment - Part 1-11 General requirement for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6 General requirements for basic safety and essential performance – Collateral standard: Usability.
USABILITY STUDY:
A usability study has been performed and showed that users were able to use the device correctly and safety.
CONCLUSION:
The electrical stimulation provided by the LL TENS 160A and LL TENS 160B is similar to that commonly employed by TENS devices that have been cleared for marketing without prescription labeling (i.e. OTC).
LL TENS 160A and LL TENS 160B have the same intended use and the same technical characteristics as the OTC cleared predicate device, Pain Buddy [510(k) No.: K102051].
The differences between LLTENS and the predicate device do not raise questions on safety and effectiveness. In other words, LL TENS 160A and LL TENS 160B are as safe as the predicate device.
Thus, the new device LL TENS 160A and LL TENS 160B are substantially equivalent to the predicate device.