(277 days)
Not Found
No
The description details a standard electrical muscle stimulation (EMS) device with pre-programmed settings and adjustable intensity and time. There is no mention of adaptive algorithms, learning capabilities, or any technology that would typically be associated with AI or ML. The device's functionality is based on fixed programs and user-controlled parameters.
No
The device description explicitly states, "it is not intended as a therapy for any medical condition." Therefore, it is not a therapeutic device.
No.
The device is intended for muscle stimulation to improve performance, not for diagnosing any medical condition. The description explicitly states, "it is not intended as a therapy for any medical condition."
No
The device description explicitly states it is a "portable two-channel, battery operated neuromuscular electronic stimulation system" and mentions hardware components like batteries, an LCD display, and electrodes. While software verification is mentioned, the core device is a physical hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "stimulation of healthy muscles in order to improve or facilitate muscle performance." This is a physical function, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description clearly states it is a "muscle stimulation device" and a "neuromuscular electronic stimulation system." It works by applying electrical impulses to muscles.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens outside of the body to diagnose diseases or conditions.
IVD devices are specifically designed to perform tests on biological samples to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on stimulating muscles externally.
N/A
Intended Use / Indications for Use
The Well-Life OTC EMS System / model no. WL-2412(A) is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
Product codes (comma separated list FDA assigned to the subject device)
NGX
Device Description
The Well Life OTC EMS System, model no. WL-2412(A) is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance; it is not intended as a therapy for any medical condition. Basically the model WL-2412(A), powered by 4.5V (3xAAA/Alkaline battery), is muscle stimulation device and identical to the SE predicate device - Slendertone EnerVive, Type 561, vith the following features:
- It is a portable two-channel, battery operated neuromuscular electronic stimulation system.
- It contains 6 programs as the predicate device; the output waveform is selectable pre-programming change among P1~P6
- The output strength is adjustable at 0
80mA via requlated voltage, with variable setting time 560 minutes counting from switching ON. - The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low indication.
- The device uses exactly Ultrastim Electrode (K000947) same as predicate device, providing as stimulation transmission media.
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
healthy adults
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)
The verification and validation tests contained in this submission demonstrate that the WL-2412(A) could maintain the same safety and effectiveness as that of cleared device.
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
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the title of a document, which is a 510(K) Summary. The text "well life" is shown above the title, along with a butterfly image. The text "Page 1 of 4" is shown below the title.
JUL - 1 2011
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K102786
-
- Submitter's Identifications: Well Life Healthcare Limited 1F., No. 16, Lane 454, Jungjeng Road, Yunghe City, Taipei County 234, Taiwan, ROC
Contact: Jenny Hsieh Telephone: + 886 2 2928 2112
- Submitter's Identifications: Well Life Healthcare Limited 1F., No. 16, Lane 454, Jungjeng Road, Yunghe City, Taipei County 234, Taiwan, ROC
Date of Summary Preparation: May 25,2011
-
- Name of the Device:
Trade Name : Well-Life OTC EMS Systems / Model : WL-2412(A) Common Name : Powered Muscle Stimulator, OTC Classification Name: Stimulator, muscle, Powered, for muscle conditioning Product Code : NGX Regulation Class : II Regulation Number : 890,5850
- Name of the Device:
4. Device Description:
The Well Life OTC EMS System , model no. WL-2412(A) is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance ; it is not intended as a therapy for any medical condition .
Basically the model WL-2412(A), powered by 4.5V (3xAAA/Alkaline battery), is muscle stimulation device and identical to the SE predicate device - Slendertone EnerVive , Type 561, vith the following features:
1
Image /page/1/Picture/0 description: The image shows the text "510(K) Summary Page 2 of 4". Above the text is a logo that says "wetlife" with a butterfly image. The text is underlined.
- It is a portable two-channel, battery operated neuromuscular electronic stimulation system.
- It contains 6 programs as the predicate device; the output waveform is selectable pre-programming change among P1~P6
- The output strength is adjustable at 0
80mA via requlated voltage, with variable setting time 560 minutes counting from switching ON. - The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low indication.
- The device uses exactly Ultrastim Electrode (K000947) same as predicate device , providing as stimulation transmission media.
-
- Intended Use:
The Well-Life OTC EMS System / model no. WL-2412(A) is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance .
-
- Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ANSI/AAM, NS4-1985, as well as EN 60601-1, and EN 60601-1-2 requirement.
- Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software quidance.
7. Conclusions
The Well-Life OTC EMS System / model no. WL-2412 (A) , by applying the same stimulus parameters and used with same type of stimulation transmission media by Ultrastim Electrode (K000947), has the same intended use as the cleared device- Slendertone EnerVive 561( K071666).
A summary of the technological characteristics of WL-2412(A) side-by side comparison to the predicate device is given below :
2
510(K) Summary Page 3 of 4
| SLENDERTONE | Well-Life OTC System, | |||
|---|---|---|---|---|
| Attribute | EnerVive 561 | WL-2412(A) | ||
| (this submission) | Discussion of Difference | |||
| 510(k)K071666 | ||||
| Design | Muscle Stimulator | Muscle Stimulator | same | |
| Size: 104×63.4×30 mm | Size: 90×52.5×18.9 mm | |||
| Waveform | Symmetrical biphasic | |||
| square | Symmetrical biphasic | |||
| square | Same | |||
| Channels | Dual | Dual | Same | |
| Power supply | 9V | 4.5V | same | |
| Material | Unit Housing -ABS | Unit Housing -ABS | same | |
| plastic | plastic | |||
| Number of Self-Adhesive Electrodes | 2 pairs of butterfly | |||
| gel pads type 719 | 2 pairs of ULB 355 | Same supplier | ||
| 510(k) 000947 cleared | ||||
| Nos. of Programs | 6 | 6 | Same | |
| Amplitude (mA) | 0~80 | 0~80 | Same | |
| Pulse rate (Hz) | 4~99 | 4~99 | Same | |
| Pulse width (µS) | 200~300 | 200~300 | Same | |
| Power ON indicator | LCD | LCD | Same | |
| Pulse Width (µS) | 200-300 | 200~300 | Same | |
| Frequency (Hz) | 4-99 | 4-99 | Same | |
| Maximum Phase charge (µC) | ||||
| @500Ω | 28.4 | 28.4 | Same | |
| Maximum Current Density (mA/cm²) | ||||
| @500Ω | 0.1485 | 0.1485 | Same | |
| Maximum Power Density (W/cm²) | ||||
| @500Ω | 0.00594 | 0.00594 | Same | |
| RMS Voltage (RMSV) (±20%) | @ 500Ω | 7.5V | 8.8 V | The max. deviation between |
| WL-2412(A) and K071666 is | ||||
| 17.3%, within the acceptable | ||||
| deviation range ((±20%). | ||||
| *Deviation 17% at @ 500Ω , | ||||
| *Deviation 9.6% at @ 1kΩ | ||||
| *Deviation 1.1% at @ 1.5 kΩ | ||||
| @ 1KΩ | 12.5V | 11.7V | ||
| @ 1.5KΩ | 13.7V | 13.8V | ||
| @ 2kΩ | - | 16.3V | ||
| @ 10kΩ | - | 27.2V | ||
| RMS Current (RMSA) | ||||
| (±20%), | @ 500Ω | 15mA | 17.6mA | |
| @ 1KΩ | 12.5mA | 11.7mA | ||
| @ 1.5kΩ | 9.1mA | 9.2mA | ||
| @ 2kΩ | - | 8.15mA | ||
| @ 10kΩ | - | 2.72mA | ||
| Prescription or OTC | OTC | OTC | Same | |
3
Image /page/3/Picture/0 description: The image shows the end of a document, specifically page 4 of 4, which is a 510(K) summary. At the top of the page is a logo that appears to be a butterfly with the word "wellife" written across the wings. The text "510(K) Summary" is written in a large font, and the page number is written below it.
The verification and validation tests contained in this submission demonstrate that the WL-2412(A) could maintain the same safety and effectiveness as that of cleared device.
ﺳ ﺳﮯ ﺳ
i
In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Well-Life Healthcare, Limited % Ms. Jenny Hsieh 1F1., No. 16, Lane 454, Jungjeng Road Yunghe City, Tiapei County China (Taiwan) 234
JUL - 1 2011
Re: K102786
Trade/Device Name: Well-Life OTC EMS System/Model WL-2412(A) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: June 30, 2011 Received: June 30, 2011
Dear Ms. Hsieh:
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. Iisting 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
5
Page 2 - Ms. Jenny Hsieh
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/CDRHOffices/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/ReportalProblem/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 vours.
E. Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications For Use
510(k) Number (if known): K102786
Device Name: Well-Life OTC EMS System / Model : WL-2412(A)
Indications For Use:
The Well-Life OTC EMS System / model no. WL-2412(A) is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance .
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (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 Surgical, Orthopedic, and Restorative Devices
5.10(k) Number K102786