(46 days)
Not Found
No
The device description and performance studies focus on basic electrical stimulation parameters and safety standards, with no mention of AI or ML. The controls are described as simple rotate buttons and switches.
Yes
The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, with an intended use for symptomatic relief of chronic intractable pain, acute post-traumatic pain, or acute post-surgical pain, fitting the definition of a therapeutic device.
No
The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, which delivers electrical current to nerves. Its stated intended use is for symptomatic relief of pain, and there is no mention of it being used to diagnose a medical condition or to identify the cause of pain.
No
The device description explicitly details physical hardware components including a molded plastic case, switches, battery storage, cables, and electrodes, indicating it is a hardware device with electrical stimulation capabilities, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain." This describes a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a "Transcutaneous Electrical Nerve Stimulator (TENS)" which sends electrical current to nerves through the skin. This is a physical therapy modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, 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
The device's function is to provide pain relief through electrical stimulation, which is a therapeutic intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
- Symptomatic relief of chronic intractable pain,
- Post traumatic pain
- Post surgical pain
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
TENS Series Electro-Stimulator, which includes models TENS 2800 and TENS 3000, are Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves through the cable and electrode placed on the skin. The parameters of units are controlled by the rotate buttons. Its intensity level is adjustable according to the needs of patients.
These TENS electro-stimulator have the same housing in a molded portable plastic case, an accessible, switch, and accessible battery storage compartment. The case shape is rectangular, The process to set the parameter and attach lead wires to the two models is also the same except the Housing printing artwork, Mode No.
TENS 3000 stimulator has three treatment mode: normal mode, burst mode and modulation mode. The treatment mode can by selected by switch. TENS 2800 only one treatment mode: normal mode. The difference on the two device can be identified by panel, Mode No.
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)
TENS Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards:
- IEC 60601-1 "Medical electrical equipment Part 1: General requirements for safety". >
- IEC 60601-1-2 "Medical electrical equipment Part 1-2: General requirements for safety -A Collateral Standard"
- IEC 60601-2-10 "Medical electrical equipment Part 2: Particular requirements for the safety of > nerve and muscle stimulators"
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
$\qquad 510(k):$
KOALATY PRODUCTS, INC.
A Current Solutions Company
File No: WMI-04-TENS -FDA-05 Version: 1.1
AUG 3 1 2010
510(k) SUMMARY
TENS Electro-Stimulator, K(102014 )
4/15/2010 Date of Submission:
Koalaty Products.,INC 510(k) Submitter's Name:
3814 Woodbury Dr Austin TX 78704 Address:
510(k) Correspondent contact: Kang Jian Ping microcong@gmail.com E-mail: Telephone: +86(755) 27652471 +86(755) 27652674 Fax:
Section 05-Page 1 of 4
1
Image /page/1/Picture/0 description: The image shows the logo for KoalaTY Products, INC. The logo features a stylized image of a koala's head on the left. To the right of the koala image, the text "KoalaTY Products, INC." is written in a simple, sans-serif font. Below the company name, the text "A Current Solutions Company" is written in a smaller font.
File No: WMI-04-TENS -FDA-05 Version: 1.0
1. Proposed Device:
Trade Name: TENS 2800 Stimulator TENS 3000 Stimulator Classification Name: Stimulator, Nerve, Transcutaneous. For pain relief Regulation Number: 882.5890 Product Code: GZJ Device Class: ||
2. Predicate Device:
Predicate Device: LT3001 TENS Stimulator 510(k) Number: K100117 Manufacturer: Shenzhen Dongdixin Technology Co., Ltd.
Description of Proposed Device: 3.
TENS Series Electro-Stimulator, which includes models TENS 2800 and TENS 3000, are Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves through the cable and electrode placed on the skin. The parameters of units are controlled by the rotate buttons. Its intensity level is adjustable according to the needs of patients.
These TENS electro-stimulator have the same housing in a molded portable plastic case, an accessible, switch, and accessible battery storage compartment. The case shape is rectangular, The process to set the parameter and attach lead wires to the two models is also the same except the Housing printing artwork, Mode No.
TENS 3000 stimulator has three treatment mode: normal mode, burst mode and modulation mode. The treatment mode can by selected by switch. TENS 2800 only one treatment mode: normal mode. The difference on the two device can be identified by panel, Mode No.
Proposed Device Intended Use Statement: 4.
Device Name:
TENS 2800 Stimulator, TENS 3000 Stimulator
Indications for Use:
- Symptomatic relief of chronic intractable pain, 1)
- Post traumatic pain 2)
- Post surgical pain 3)
Section 05-Page 2 of 4
2
KOALATY PRODUCTS, INC.
A Current Solutions Company
File No: WMI-04-TENS -FDA-05 Version: 1.0
5. Biocompatibility Certification:
Electrodes to be provided with this device are from the manufacturer Top-Rank Health Care Equipment Co., Ltd (K070612) who submitted in 2007.
The shell of device is used ABS material; this material has passed Biocompatibility testing in Jiangsu TUV Product Service Ltd. Shanghai Branch. Identification No: 080960.
6. Technological Characteristics and Substantial Equivalence
Both the TENS Series Electro-Stimulator and the Predicate device Stimulator have the same intended use and fundamental technology. A side-by-side comparison of the TENS Series Electro-Stimulator and the cited predicate devices is included in the 510(k) submission. The TENS Series Electro-Stimulator is substantially equivalent to the technological features as the predicate devices.
| New device | Predicate device | ||
|---|---|---|---|
| 1 | 510K# | K | K100117 |
| 2 | Device Name | TENS 2800 Stimulator | |
| TENS 3000 Stimulator | LT3001 TENS Stimulator | ||
| 3 | Manufacturer | Koalaty Products., INC | Shenzhen Dongdixin |
| Technology Co., Ltd. | |||
| 4 | Power Source | 9V Battery | 9V Battery |
| -Method of Line current isolation | Battery Supply N/A | Battery Supply N/A | |
| - Patient Leakage Current | |||
| -Normal condition | |||
| -Single fault condition | 1.2uA | ||
| 1.3uA | 1.1uA | ||
| 1.3uA | |||
| 5 | Number of Output Modes | 3 | 6 |
| 6 | Number of Output Channels | 2 | 2 |
| Method of channel isolation | By enclosure | By enclosure | |
| 7 | Regulated Current or regulated | ||
| Voltage? | Voltage control | Voltage control | |
| 8 | Software/Firmware/ | ||
| Microprocessor Control? | Yes | Yes | |
| 9 | Automatic Overload Trip? | No | No |
| Automatic Over Current Trip? | No | No | |
| 10 | Automatic No Load Trip? | No | No |
| 11 | Automatic Shut off? | No | No |
| 12 | Patient Override Control? | No | No |
| 13 | Indicator Display | ||
| -On/Off Status? | Yes | Yes | |
| -Voltage/Current Level? | Yes | Yes | |
| -Low Battery? | Yes | Yes |
Basic technological characteristics, new device vs. Predicate device
Section 05-Page 3 of 4
3
Image /page/3/Picture/0 description: The image shows the logo for KoalaTY Products, INC. The logo features a stylized image of a koala's head on the left. To the right of the koala image, the text "KoalaTY Products, INC." is written in a bold, sans-serif font. Below the company name, the text "A Current Solutions Company" is written in a smaller, lighter font.
| 14 | Timer Range (minutes) | 15min, 30min, continue | 30min, 60min, continue |
|---|---|---|---|
| 15 | Waveform | Biphasic or Monophasic | |
| Rectangular pulse | Biphasic Rectangular pulse | ||
| 16 | Pulse Width Range | 30-260us | 50-300us |
| 17 | Frequency | 2-150Hz | 2-120Hz |
| 18 | Compliance with Voluntary Standards | IEC60601-1, IEC60601-1-2, | |
| IEC60601-2-10 | IEC60601-1, IEC60601-1-2, | ||
| IEC60601-2-10 | |||
| 19 | Compliance with 21 CFR 898? | Yes | Yes |
| 20 | Weight (grams.) | 115 grams(battery included) | 128 grams (battery included) |
| 21 | Dimensions (mm.) H x W x T | 95x65x23.5 | 102x64x26 |
| 22 | Housing Materials & Construction | Enclosure: ABS,94, V-1,80°C,UL Approved | Enclosure: ABS,94, V-1,80°C,UL |
| Approved |
Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:
TENS Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards:
- IEC 60601-1 "Medical electrical equipment Part 1: General requirements for safety". >
- IEC 60601-1-2 "Medical electrical equipment Part 1-2: General requirements for safety -A Collateral Standard"
- IEC 60601-2-10 "Medical electrical equipment Part 2: Particular requirements for the safety of > nerve and muscle stimulators"
Conclusions: 8.
The TENS Series Stimulator, which includes models TENS 2800 and TENS 3000, has the same intended use and technological characteristics as the predicate device. Moreover, bench testing, safety report and Risk Analysis Report documentation supplied in this submission demonstrates that the difference in the submitted models could maintain the same safety and effectiveness as that of predicate device. In the other words, those engineering difference do not affect the intended use or alter the fundamental scientific technology of the device. Thus, the TENS Series Electro-Stimulator is substantially equivalent to the predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is smaller than the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Koalaty Products, Inc. c/o Mr. Jeffrey D. Rongero Senior Project Engineer, UL Health Sciences Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle, NC 27709
AUG 3 1 2010
Re: K102014
Trade/Device Name: TENS 2800, TENS 3000 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Codes: GZJ Dated: August 11, 2010 Received: August 16, 2010
Dear Mr. Rongero:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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
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/ucm].15809.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,
Kesia 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
KID2014
File No: WMI-04-TENS-FDA-04 Version: 1.1
Indications for Use
AUG 31 2010
510(k) Number (