(154 days)
No
The description details a standard electrical muscle stimulator with pre-set programs and no mention of adaptive or learning capabilities.
No.
A therapeutic device is typically used for the treatment, prevention, or diagnosis of a disease or condition. This device is indicated for muscle toning and strengthening, which is a cosmetic or fitness application rather than a therapeutic one.
No
The device description clearly states it is a "muscle stimulation system specifically designed to exercise the abdominal muscles" and its intended use is for "improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for the development of a firmer abdomen." These are therapeutic and fitness goals, not diagnostic ones.
No
The device description clearly states it is a "two-channel battery operated muscle stimulation system" with "an electronic stimulator module" and an "abdominal electrode belt," indicating it is a hardware device with software components, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Flex Max Function: The Flex Max by Slendertone is a muscle stimulation system that applies electrical signals to the skin to stimulate abdominal muscles. It works externally on the body and does not involve analyzing any biological samples.
- Intended Use: The intended use clearly states it's for improving muscle tone, strengthening, and developing a firmer abdomen. This is a physical therapy/fitness application, not a diagnostic one.
Therefore, based on the provided information, the Flex Max by Slendertone is a muscle stimulator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Flex Max by Stendertone is indicated for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for the development of a firmer abdomen.
Product codes
NGX
Device Description
Flex Max by Slendertone, Type 517-US is a two-channel battery operated muscle stimulation, system specifically designed to exercise the abdominal muscles. It offers 10 programs to the user and comprises of two main components, an electronic stimulator module which generates the required stimulation signals and an abdominal electrode belt, which connects the signals from the stimulator to the skin electrodes located on the inner surface of the belt.
The product is supplied with a double set of double-sided adhesive electrodes, a double set of batteries, an extender belt and an instruction manual. Power is derived from 3 x 1.5 volt (LR03) batteries located in a compartment protected by a removable battery cover. Instructions are provided in the user instructions.
For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal muscles
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)
The same technological platform and modus operandi is same as the predicate device, Slendertone Flex, Type 515. No additional clinical studies were provided as part of this The Flex Max by Slendertone complies with international standards for submission. electrical safety and electromagnetic compatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
7AUG 02
IL100554
This summary is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Contact Details
| Name: | Deirdre Barrow |
|---|---|
| Address: | Bio-Medical Research Ltd., |
| Parkmore Business Park, West | |
| Galway, Ireland | |
| Telephone: | +353 91 774300 |
| Fax: | +353 91 774301 |
| E-Mail: | dbarrow@bmr.ie |
| Alternate Contact: | Michael O'Sullivan |
| Address: | Bio-Medical Research Ltd., |
| Parkmore Business Park, West | |
| Galway, Ireland | |
| Telephone: | +353 91 774300 |
| Fax: | +353 91 774301 |
Prepared:
.
25th May 2010
2. Device Name
| Trade Name of Device: | Flex Max by Slendertone, Type 517-US |
|---|---|
| Common Name: | Muscle Stimulator |
| Classification Name: | Stimulator, muscle, powered, for muscle conditioning |
| Regulation Number: | 21 CFR 890.5850 |
| Product Code: | NGX |
3. Identification of Equivalent Legally Marketed Device
| Name: | Slendertone Flex, Type 515 |
|---|---|
| Manufacturer: | Bio-Medical Research Ltd. |
| 510(k) No: | K030708, June 2003 |
1
4. Description of Device
Flex Max by Slendertone, Type 517-US is a two-channel battery operated muscle stimulation, system specifically designed to exercise the abdominal muscles. It offers 10 programs to the user and comprises of two main components, an electronic stimulator module which generates the required stimulation signals and an abdominal electrode belt, which connects the signals from the stimulator to the skin electrodes located on the inner surface of the belt.
The product is supplied with a double set of double-sided adhesive electrodes, a double set of batteries, an extender belt and an instruction manual. Power is derived from 3 x 1.5 volt (LR03) batteries located in a compartment protected by a removable battery cover. Instructions are provided in the user instructions.
For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.
5. Statement of Intended Use & Indications for Use
The Flex Max by Slendertone device has the same intended use and indications for use as the listed equivalent legally marketed device. It is intended for use by healthy persons to apply transcutaneous neuromuscular electrical stimulation ("NMES") through skin contact electrodes for the purpose of improving abdominal muscle tone, strength and firmness.
6. Technological Characteristics
The Flex Max by Slendertone device is identical to the predicate device in design, materials, mode of operation, and methods of manufacture. It differs only in the addition of different program offerings to the user.
7. Clinical and Non-Clinical Tests
The same technological platform and modus operandi is same as the predicate device, Slendertone Flex, Type 515. No additional clinical studies were provided as part of this The Flex Max by Slendertone complies with international standards for submission. electrical safety and electromagnetic compatibility.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Bio-Medical Research, Ltd. % Ms. Deirdre Barrow BMR House, Parkmore Business Park West Galway, Ireland
Re: K100556
Trade Name: Flex Max by Slendertone, Type 517-US Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: May 25, 2010 Received: June 4, 2010
AUG 02-2010
Dear Ms. Barrow:
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 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
3
Page 2 - Ms. Deirdre Barrow
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/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 yours,
Mark A. Melkersen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
4
AUG 02 2010
Indications for Use
510(k) Number (if known):
Device Name:
Flex Max by Slendertone, Type 517-US
Indications for Use:
Flex Max by Stendertone is indicated for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for the development of a firmer abdomen.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter. Use AND/OR (21 CFR 801 Subpart C) X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Yurman W. Clary
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100556