(56 days)
Not Found
None
No
The summary describes a muscle stimulation device with no mention of AI or ML technology, image processing, or data sets typically associated with AI/ML development.
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 "Intended Use / Indications for Use" states that the device is for "improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles" and explicitly says "Not 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 "Fitness Belt (Model: KLT-07)", which implies a physical hardware component (a belt) is part of the device. The intended use also describes the application of this belt to specific anatomical areas.
Based on the provided information, the Fitness Belt is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Fitness Belt's intended use is for the improvement of muscle tone, strengthening, and development of firmer muscles through external application to the body.
- The description explicitly states it is "Not intended for use in any therapy or for the treatment of any medical conditions or diseases." This further reinforces that it's not for diagnostic or treatment purposes related to internal bodily processes.
Therefore, the Fitness Belt falls under the category of a physical fitness or muscle stimulation device, not an IVD.
N/A
Intended Use / Indications for Use
The Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles.
-
The big belt is intended for use on the muscles in abdomen.
-
The small belt is intended for use on the muscles in arms and thighs areas.
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.
Product codes
NGX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen, arms, thighs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services - USA. To the right of the seal is the FDA logo in blue, with the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" to the right of the square.
June 16, 2023
Shenzhen KeLuTongDa Industrial Co., Ltd. % Doris Dong General Manager Shanghai CV Technology Co., Ltd. Room 602, No. 19 Dongbao Road Songjiang Area, Shanghai 201613 China
Re: K231136
Trade/Device Name: Fitness Belt (Model: KLT-07) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: April 17, 2023 Received: April 21, 2023
Dear Doris Dong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231136
Device Name Fitness Belt (Model:KLT-07)
Indications for Use (Describe)
The Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles.
-
The big belt is intended for use on the muscles in abdomen.
-
The small belt is intended for use on the muscles in arms and thighs areas.
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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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