Fitness Belt (Model: KLT-07)
Device Facts
| Record ID | K231136 |
|---|---|
| Device Name | Fitness Belt (Model: KLT-07) |
| Applicant | Shenzhen Kelutongda Industrial Co., Ltd. |
| Product Code | NGX · Physical Medicine |
| Decision Date | Jun 16, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
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.
Device Story
Fitness Belt (Model: KLT-07) is a powered muscle stimulator for over-the-counter use. Device applies electrical stimulation to muscles in abdomen (big belt) and arms/thighs (small belt) to improve tone and strength. Intended for healthy individuals; not for medical therapy or treatment of conditions. Contraindicated for injured or impaired muscles.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Powered muscle stimulator; electrical stimulation output; belt form factor; intended for OTC use.
Indications for Use
Indicated for improvement of muscle tone, strengthening, and development of firmer muscles in abdomen, arms, and thighs. Contraindicated for use on injured or impaired muscles. Not for medical therapy or treatment of disease.
Regulatory Classification
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.
Related Devices
- K091833 — GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. · Gemore Technology Co, Ltd. · Oct 16, 2009
- K102295 — X2ABS DUAL CHANNEL FITNESS BELT · Leto Enterprises Incorporation · Feb 18, 2011
- K182136 — Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) · Shenzhen Osto Technology Co., Ltd. · Oct 10, 2019
- K202653 — Gymform Total ABS · Well Brain International , Ltd. · Jan 15, 2021
- K233035 — Electronic Muscle Stimulator (Model MP01) · Shenzhen Hengbosi Industrial Co., Ltd. · Jan 8, 2024
Submission Summary (Full Text)
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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.
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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
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## 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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