(209 days)
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," indicating it is not a therapeutic device.
No
The device description and intended use explicitly state that it is for muscle improvement (tone, strengthening, firmer muscles) and specifically states "[n]ot intended for use in any therapy or for the treatment of any medical conditions or diseases," which indicates it is not a diagnostic device.
No
The device description explicitly states it is comprised of an electronic stimulator module and a belt 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 the improvement of muscle tone, strengthening, and development of firmer muscles on the abdominal muscles. This is a physical effect on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a muscle stimulation system that applies electrical signals to the skin via electrodes. This is a physical intervention, not a diagnostic process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Body Control is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal muscles.
Product codes (comma separated list FDA assigned to the subject device)
NGX
Device Description
Body Control is a 2 channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module which generates the required stimulation signals.
Body Control is comprised of a belt 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 belts. 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
abdominal muscles
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.
Performance data was 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
:
Image /page/0/Picture/1 description: The image shows the logo for SPORT-ELEC. The logo is in black and white, with the words "SPORT-ELEC" in large, bold letters. Below the main logo, the words "ELECTRO-MUSCULATION" are written in a smaller font. The logo appears to be for a company that specializes in electro-muscle stimulation products.
PREMARKET NOTIFICATION 510(K) TRADITIONAL SUBMISSION
Body Control
14
.
| 5. 510(K) SUMMARY | ||
|---|---|---|
| [As Required by 21 CFR 807.92] | ||
| Summary of Safety and Effectiveness | ||
| 1 | Submitter | SPORT-ELEC |
| Route de Rouen | ||
| 27520 Bourgtheroulde |
S.A.
BP 35
France
NOV - 5 2008 |
| | 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 | Jan 10, 2008 |
| 2 | Device name | Body Control |
| | Trade Name | SPORT-ELEC® |
| | Common Name | Powered Muscle stimulator |
| | Product code and
classification name | Stimulator, muscle, powered for muscle conditioning
(NGX)
21 CFR Section 890.5850 |
| 3 | Predicate devices | SPORT-ELEC ABDOMINAL Training System,
manufactured by |
| | | Sport-Elec REF CT 5 K061914 Cleared July 26th
2007 |
| 4 | Description | Body Control is a 2 channel battery operated muscle
stimulation system specifically designed to exercise the
abdominal muscles. It is comprised of an electronic
stimulator module which generates the required
stimulation signals. |
| | | Body Control is comprised of a belt 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 belts. The product is supplied
with the cream VC 57B/53 -148, a User's Guide and a
carry case. |
| | Explanation of how | Power is derived from 3 batteries located in a |
| | the device operates | compartment protected by a removable battery cover for
the Body Control. |
| | | The electrodes are integrated in the inner surface of the
belt. The garment is worn secured by hooks and loops
fastening patches. |
| | | There is no current passed from side to side. The user
cannot access the wiring or connectors within the belt. |
1
SPORT-ELEC®
6
PREMARKET NOTIFICATION 510(K) TRADITIONAL SUBMISSION
The Body Control device is intended for use by healthy Intended use persons to apply trans-coetaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes;
- Improvement of muscle tone of the muscles in the abdomen.
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.
Performance data was also verified versus the requirements of the FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices.
Substantial equivalence The technological summary
characteristics, features, specifications, materials, mode of operation, and intended use of the Body Control device is substantially equivalent to the predicate device quoted above.
The differences that exist between the devices do not raise new issues of safety or effectiveness regarding the Body Control Device.
The Body Control is the same as the CT5 Abdominal training system in its delivery of the stimulation signal and has similar parameter settings. There are similar restrictions between the two devices in that electrode positioning is governed by and is integrated into the garment.
15
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services (USA). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sport-Elect S.A. % FDA Registrar Corp Ms. Sharon Scannell Senior Compliance Specialist 144 Research Drive Hampton, Virginia 23666
NOV - 5 2008
K081026 Re:
Trade Name: Body Control Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 15, 2008 Received: October 27, 2008
Dear Ms. Scannell:
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 such 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); good manufacturing practice requirements as set
3
Page 2 - Ms. Sharon Scannell
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) promarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Mark N. Mullin
Mark N. Melkerson Director Division of General, Restorative and Neurological 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 logo for SPORT-ELEC, a company specializing in electro-musculation. The words "SPORT-ELEC" are written in large, bold, sans-serif font. Below the company name, the words "ELECTRO-MUSCULATION" are written in a smaller, sans-serif font.
PREMARKET NOTIFICATION 510(K) TRADITIONAL SUBMISSION
Body Control
13
- INDICATIONS FOR USE AND ASSOCIATIONS FOR MODE
510(k) Number (if known):
Device Name:
Body Control
Indications for Use: Body Control is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(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)
CARD THE COURT FOR COURT COLLECT CAR CAR CAR SELL CONSULT AND SCHENCY U T COLL
Nithan Kumar
Vision of General, Restorative, nd Neurological Devices
:(k) Number K081026