AB COMMAND DUAL CHANNEL FITNESS BELT

{0}------------------------------------------------ # K122414 | Sponsor: | Leto Enterprises Incorporation | |-----------------|--------------------------------------| | Subject Device: | AB COMMAND Dual Channel Fitness Belt | | File No.: | 510(k) submission report, Section 9 | #### Section 9 510 (k) Summary This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. ### 1. Submitter's Information 510(k) Owner's Name: Leto Enterprises Incorporation Address: 19/F, Nan Dao Commercial Bldg, 359-361 Queen's Road Central, Hong Kong, China Phone: (852) 3694 0110 Fax: (852) 2515 3995 Contact Person: Choi Chui Ngan E-mail: dir@leto-ent.com #### Contact Person of the Submission: A Ms. Sabrina Wei MEDLAB (Shenzhen) Information Service Co., LTD B102, Nanshan Medical Device Industrial Park, No. 1019 of Nanhai Avenue, Nanshan District,Shenzhen, Guangdong, P. R. China, 518000 TEL: +86-755- 8632 9133 FAX: +86-755- 8632 9134 E-mail: sabrinawei@hotmail.com #### 2. Device Information | Trade Name: | AB COMMAND Dual Channel Fitness Belt | |----------------------|------------------------------------------------------| | Common Name: | Powered muscle stimulator | | Classification name: | Stimulator, Muscle, Powered, For muscle conditioning | | Review Panel: | Physical Medicine | | Product Code: | NGX | | Regulation Class: | II | | Regulation Number: | 890.5850 | #### 3. Predicate Device Information | Submitter: | Leto Enterprises Incorporation | |----------------|---------------------------------| | Device Name: | X2ABS Dual Channel Fitness Belt | | 510(K) Number: | K102295 | Report by MEDLAB (Shenzhen) Information Service Co., Ltd. Page 9-1 {1}------------------------------------------------ Leto Enterprises Incorporation Sponsor: AB COMMAND Dual Channel Fitness Belt Subject Device: 510(k) submission report, Section 9 File No .: ### 4. Device description AB COMMAND Dual Channel Fitness Belt is a two channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module for signal generation, a belt for fixation, and four electrodes for signal connection to skin. The built-in electrodes are located on the inner surface of the belts. Power is derived from 2 batteries located in a compartment protected by a removable battery cover for the Fitness Belt. There is no current passed from side to side. The user cannot access the wiring or connectors within the belt. The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level can be adjustable by user. #### 5. Intended Use The AB COMMAND Dual Channel Fitness Belt is intended for use by healthy persons to apply trans-coetancous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen. #### 6. Indications for Use The AB COMMAND Dual Channel Fitness Belt 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. #### 7. Performance Summary Testing has been 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 has been verified according to the requirements of the FDA Guidance for Pre Market Submissions and for Software Contained in Medical Devices. The waveform test report has also been provided to verify the parameters of the device. #### 8. Comparison to predicate device and conclusion The Intended Use, Indications for Use, technological characteristics, features, Report by MEDLAB (Shenzhen) Information Service Co., Ltd. Page 9-2 {2}------------------------------------------------ Leto Enterprises Incorporation Sponsor: AB COMMAND Dual Channel Fitness Belt Subject Device: 510(k) submission report, Section 9 File No.: specifications, materials, operation, and software of AB COMMAND Dual Channel Fitness Belt are substantial cquivalent to the predicate device X2ABS Dual Channel Fitness Belt. The main differences between the subject device and predicate device are the trade mark, dimension and art design of belt, package bag and box. These differences will not raise new issues of safety and effectiveness. 9. Date of the summary prepared: September 29, 2012 #### Report by MEDLAB (Shenzhen) Information Service Co., Ltd. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming the staff and a serpent winding around it. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 21 December 2012 Leto Enterprises Incorporation % Ms. Sabrina Wei Medlab (Shenzhen) Information Service Co., Ltd. Suite A-2706, Zhongfang Jingyuan, Xinwen Road, Futian District Shenzhen, Guangdong 518100 China Re: K122414 Trade/Device Name: AB Command Dual Channel Fitness Belt Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: Undated Received: November 26, 2012 Dear Ms. Wei: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the energed of to the enactment date of the Medical Device Amendments, or to commerce pror to they 20, 2017, 12, 12, 2017, 11:22 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 adulton. Thease noter u, 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 r lease be devisou alle 1 Dr mination that your device complies with other requirements of the Act that I Dri has made a associations administered by other Federal agencies. You must {4}------------------------------------------------ Page 2 - Ms. Sabrina Wei 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 Of K I art 007), acomig (21 CFR 803); good manufacturing practice requirements as set de rece related daverse overse) (2 - Entation (2) CFR Part 820); and if applicable, the electronic roral in also quino 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 the Concertified, "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 Tou may 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, Victor Krauthamer -S Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Leto Enterprises Incorporation Sponsor: AB COMMAND Dual Channel Fitness Belt Subject Device: 510(k) submission report, Section 5 File No.: ### 3. Indications for Use 510(k) Number (if known): KIZZYIY Device Name: AB COMMAND Dual Channel Fitness Belt Indications for Use: The AB COMMAND Dual Channel Fitness Belt 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 (Part 21 CFR 801 Subpart D) Over-The-Counter Use _ X AND/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Neurological and Physical Medicine Devices 510(k) Number K122414 Report by MEDLAB (Shenzhen) Information Service Co.; Ltd. Page 5-10