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FDA 510(k)

Fitness Belt (Model: KLT-07)

K-Number: K231136 · 2023-06-16

ApplicantShenzhen Kelutongda Industrial Co., Ltd.
Decision Date2023-06-16
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Fitness Belt (Model: KLT-07) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kelutongda Industrial Co., Ltd.. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K231136. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fitness Belt (Model: KLT-07)?

Fitness Belt (Model: KLT-07) is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Shenzhen Kelutongda Industrial Co., Ltd.. The 510(k) number is K231136.

When did Fitness Belt (Model: KLT-07) receive FDA 510(k) clearance?

Fitness Belt (Model: KLT-07) received FDA 510(k) clearance on 2023-06-16, under 510(k) number K231136.

Who is the listed applicant for Fitness Belt (Model: KLT-07)?

The FDA 510(k) record lists Shenzhen Kelutongda Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fitness Belt (Model: KLT-07)?

The FDA product code for Fitness Belt (Model: KLT-07) is NGX.

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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