(147 days)
Sport-Elec REF BCS K 081026, Slendertone System-Arms K 072553, Slendertone flex bottom and thighs toning system K022855
Not Found
No
The device description and performance studies focus on electrical stimulation and safety standards, with no mention of AI or ML technologies.
No
The "Intended Use / Indications for Use" section explicitly states, "Not intended for use in any therapy or for the treatment of any medical conditions or diseases."
No
The device is described as a muscle stimulation system intended for improving muscle tone and strengthening, not for diagnosing any condition. The "Intended Use" explicitly states "Not intended for use in any therapy or for the treatment of any medical conditions or diseases," which further confirms it is not a diagnostic device.
No
The device description explicitly states it comprises an "electronic stimulator module" and "accessories with integral electrodes," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for improving muscle tone and strengthening muscles in the arms and thighs. This is a physical function, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is a muscle stimulation system that applies electrical signals to the skin. This is a physical intervention, not a method for analyzing biological samples.
- No Mention of In Vitro Testing: There is no mention of analyzing samples outside of the body, which is the core characteristic of an IVD.
The device is clearly intended for external use on the body to achieve a physical effect on muscles.
N/A
Intended Use / Indications for Use
Body Control System is indicated for the improvement of arms and thighs muscles tone, for strengthening of arms and thighs muscles.
Product codes (comma separated list FDA assigned to the subject device)
NGX
Device Description
Body Control System is a 2 channel battery operated muscle stimulation system specifically designed to exercise the arms and thighs muscles, It comprises namely an electronic stimulator module which generates the required stimulation signals.
Body Control System comprises accessories with integral electrodes, which connects the signals from the stimulator to the skin. The built-in electrodes are located on the inner surface of the accessories.
The product is supplied with the cream VC 57B/53 -148, a User's Guide and a carry case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arms and thighs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthy persons
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)
Testing was carried out to assure compliance with recognized electrical safety standards:
IEC 60601-1 and -2-10 standards for electrical safety
IEC 60601-1-2 standard for electromagnetic compatibility
IEC 60601-1-4 standard for the software (ISO14971).
Performance data were also verified versus the requirements of the FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices.
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.
Sport-Elec REF BCS K 081026, Slendertone System-Arms K 072553, Slendertone flex bottom and thighs toning system K022855
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
K091/565
Image /page/0/Picture/1 description: The image contains the text "SPORT-ELEC" in a bold, sans-serif font. Below this, there is smaller text that appears to say "ELECTRO-MUSCULATION". The text is black and the background is white. The overall impression is that of a logo or brand name.
PREMARKET NOTIFICATION 510(K) SUBMISSION
Body Control System Page 5 / 23
| 5. 510(K) SUMMARY
[As Required by 21 CFR 807.92]
| Summary of Safety and Effectiveness | NOV 13 2 | ||
|---|---|---|---|
| 1 | Submitter | SPORT-ELEC S.A. | |
| Route de Rouen BP 35 | |||
| 27520 Bourgtheroulde | |||
| France | |||
| Contact Person | Karine Coral / Jean Philippe Broucke | ||
| Phone number : (+33) 2 32 96 50 50 | |||
| Fax number : (+33) 2 32 96 50 59 | |||
| Preparation date | January 21st 2009 | ||
| 2 | Device name | Body Control System | |
| Trade Name | SPORT-ELEC® | ||
| Common Name | Muscle stimulator | ||
| Code product and | |||
| classification name | Stimulator, muscle, powered for muscle conditioning (NGX) | ||
| 21 CFR Section 890.5850 | |||
| Powered Muscle Stimulator | |||
| 3 | Predicate devices | SPORT-ELEC Body Control System, manufactured by | |
| Sport-Elec REF BCS K 081026 Cleared Nov 5th 2008 and: | |||
| Slendertone System-Arms K 072553 Cleared Dec 14th 2007 | |||
| Slendertone flex bottom and thighs toning system K022855 Cleared | |||
| March 06th 2003 | |||
| 4 | Description | Body Control System is a 2 channel battery operated muscle | |
| stimulation system specifically designed to exercise the arms and | |||
| thighs muscles, It comprises namely an electronic stimulator module | |||
| which generates the required stimulation signals. | |||
| Body Control System comprises accessories with integral electrodes, | |||
| which connects the signals from the stimulator to the skin. The built-in | |||
| electrodes are located on the inner surface of the accessories. | |||
| The product is supplied with the cream VC 57B/53 -148, a User's Guide | |||
| and a carry case. | |||
| Explanation of how the | |||
| device operates | Power is derived from 3 batteries located in a compartment protected | ||
| by a removable battery cover. | |||
| The electrodes are integrated in the inner surface of the accessories. | |||
| The garment is worn as shown on picture. | |||
| There is no current passed from side to side. The user cannot access | |||
| the wiring or connectors within the accessories. | |||
| Intended use | The Body Control is intended for use by healthy persons to apply trans-coetaneous electrical muscle stimulation (EMS) through skin contact | ||
| electrodes for the following purposes; | |||
| - Improvement of muscle tone of the muscles of arms and thighs. |
1
SPORT-ELEC
ELECTRO-MUSCULATION
. ··
PREMARKET NOTIFICATION 510(K) SUBMISSION
Body Control System Page 6 / 23
:
.
| 5
Performance data | Testing was carried out to assure compliance with recognized electrical
safety standards:
IEC 60601-1 and -2-10 standards for electrical safety
IEC 60601-1-2 standard for electromagnetic compatibility
IEC 60601-1-4 standard for the software (ISO14971).
Performance data were also verified versus the requirements of the
FDA Guidance for Pre Market Submissions and for Software contained
in Medical Devices. |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6
Substantial equivalence
summary | The technological characteristics, features, specifications, materials,
mode of operation, and intended use of the Body Control System Arms
and Thighs device are substantially equivalent to the predicate devices
quoted above.
The differences that exist between the devices do not raise new issues
of safety or effectiveness regarding the Body Control System Device.
The accessories of the Body Control System Arms and Thighs use the
same as the BCS training system and Slendertone System Arms in it's
delivery of the stimulation signal and has similar parameter setting.
There are similar restrictions between the two devices in that electrode
positioning is governed by and is integrated to the garment. |
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a stylized graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement. The graphic element is a stylized representation of a human figure with outstretched arms, symbolizing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Sport-Elec % Kimberly Jones, Ph.D. Senior Regulatory Specialist Registrar Corp. 144 Research Drive Hampton, Virginia 23666
NOV 1 3 2009
Re: K091865
Trade Name: Sport-Elec Body Control System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulation Class: II Product Code: NGX Dated: November 9, 2009 Received: November 10, 2009
Dear Dr. Jones:
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.
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 - Kimberly Jones, Ph.D.
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/CDRH0ffices/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SPORT-ELEC PREMARKET NOTIFICATION 510(K) SUBMISSION
Body Control System Page 4 / 23
CATION CATION 4 4 INDICATIONS FOR USE - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
N/A 510(k) Number (if known):
Device Name:
Body Control System Arms and Thighs
Indications for Use: Body Control System is indicated for the improvement of arms and thighs muscles tone, for strengthening of arms and thighs muscles.
Contraindicated use on injured or otherwise impaired muscles
Not intended for use in any therapy or for the treatment of any medical conditions or diseases
Prescription Use Over-The-Counter Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
KIMBERLY M. TAYLOR FOR M. MELKERSON
(Division Sign-Off) (Division Sign of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091865