Fit Belt
FDA 510(k) K133108 · Hong Qiangxing (Shenzhen) Electronics Limited
510(k) numberK133108
Submission
- Device name
- Fit Belt
- Applicant
- Hong Qiangxing (Shenzhen) Electronics Limited
Shenzhen, CN - Received
- September 30, 2013
- Decision date
- August 5, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NGX – Stimulator, Muscle, Powered, For Muscle Conditioning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this…
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| K190009 | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)NUH · Traditional | 12/02/2019SE |
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Questions and answers
When was Fit Belt cleared by the FDA?
Fit Belt (K133108) received a 510(k) decision of Substantially Equivalent on August 5, 2014, 309 days after the submission was received.
What is the product code of K133108?
The FDA product code is NGX – Stimulator, Muscle, Powered, For Muscle Conditioning, a Class II (moderate risk) device regulated under 21 CFR 890.5850.