(205 days)
Not Found
No
The description focuses on electrical muscle stimulation and does not mention any AI/ML components or functionalities.
No
The "Intended Use" section explicitly states, "Not intended for use in any therapy or for the treatment of any medical conditions or diseases," indicating it's not a therapeutic device.
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," which includes diagnosis. The device is designed for muscle stimulation for tone and strengthening, not for identifying or investigating medical conditions.
No
The device description explicitly states it comprises an "electronic stimulator module" and a "short 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Body Control System is a muscle stimulation system that applies electrical signals externally to the buttocks muscles. It does not analyze any samples taken from the body.
- Intended Use: The intended use is for the improvement and strengthening of buttocks muscles, which is a physical function, not a diagnostic test.
- Device Description: The description details an external stimulator and electrodes, not equipment for analyzing biological samples.
Therefore, the Body Control System falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Body Control "BS" 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 buttocks.
Body Control System is indicated for the improvement of buttocks muscles tone, for strengthening of buttocks muscles.
Product codes (comma separated list FDA assigned to the subject device)
NGX
Device Description
Body Control System "BS" is a 2 channel battery operated muscle stimulation system specifically designed to exercise the buttocks' muscles, It comprises namely an electronic stimulator module which generates the required stimulation signals.
Body Control System "BS" comprises a short 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
buttocks
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. (ISO 14971 : 2007) 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.
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
FEB - 5 2010
.
Image /page/0/Picture/2 description: The image shows the logo for SPORT-ELEC in a bold, sans-serif font. Below the main logo, the words "ELECTRO-MUSCULATION" are printed in a smaller, sans-serif font. The logo appears to be for a sports or fitness-related product or service, possibly related to electro-muscle stimulation.
PREMARKET NOTIFICATION 510(K) SUBMISSION
Body Control System Buttock's Short Page 5 / 23
| 5. 510(K) SUMMARY
[As Required by 21 CFR 807.92]
| Summary of Safety and Effectiveness | ||
|---|---|---|
| 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 24th 2009 | |
| 2 | Device name | Body Control System "BS" |
| 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 Short K070142 Cleared March 23th 2007 | ||
| 4 | Description | Body Control System "BS" is a 2 channel battery operated muscle |
| stimulation system specifically designed to exercise the buttocks' | ||
| muscles, It comprises namely an electronic stimulator module which | ||
| generates the required stimulation signals. |
Body Control System "BS" comprises a short 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 short. 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 short. |
| | Intended use | The Body Control "BS" 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 buttocks |
1
Image /page/1/Picture/0 description: The image shows the logo for SPORT-ELEC. The text is in bold, black letters. Below the main text, there is smaller text that reads ELECTRO-MUSCULATION.
PREMARKET NOTIFICATION 510(K) SUBMISSION
Body Control System Buttock's Short Page 6 / 23
Testing was carried out to assure compliance with recognized electrical 5 Performance data 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. (ISO 14971 : 2007) Performance data were also verified versus the requirements of the FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices. The technological characteristics, features, specifications, materials, 6 Substantial equivalence mode of operation, and intended use of the Body Control System Short summary 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 short of the Body Control System "BS" use the same as the BCS training system and Slendertone System Short 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/0 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three birds in flight. The birds are depicted with curved lines, and they appear to be flying to the right. The seal is likely used to represent the U.S. Department of Health and Human Services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
FEB = 5 2010
Sport-Elec % Registrar Corp Kimberly Jones, Ph.D. Senior Regulatory Specialist Compliance Department 144 Research Drive Hampton, Virginia 23666
Re: K092142
Trade Name: Sport-Elec Body Control System "BS" Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulation Class: Class II Product Code: NGX Dated: January 21, 2010 Received: January 25, 2010
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. 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.
3
Page 2 - Kimberly Jones, Ph.D
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 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/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark A Millhuser
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the text "SPORT-ELEC" in bold, sans-serif font. Below this text is the phrase "ELECTRO-MUSCULATION" in a smaller, narrower font. The text is black and the background is white.
PREMARKET NOTIFICATION 510(K) SUBMISSION
Body Control System Buttock's Short Page 4 / 23
4. INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Body Control System "BS"
Indications for Use: Body Control System is indicated for the improvement of buttocks muscles tone, for strengthening of buttocks 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 x — 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)
KATHY M. OLSEN FOR M. MELKERSON
Division Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number: K092142