SLENDERTONE Evolve Abs, Type 735
FDA 510(k) K203513 · Bio-Medical Research, Ltd.
Submission
- Device name
- SLENDERTONE Evolve Abs, Type 735
- Applicant
- Bio-Medical Research, Ltd.
Galway, IE - Received
- November 30, 2020
- Decision date
- February 10, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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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| K110350 | Kneehab XPGZJ · Traditional | 08/03/2011SE |
| K102614 | Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40GXY · Traditional | 06/03/2011SE |
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Questions and answers
When was SLENDERTONE Evolve Abs, Type 735 cleared by the FDA?
SLENDERTONE Evolve Abs, Type 735 (K203513) received a 510(k) decision of Substantially Equivalent on February 10, 2021, 72 days after the submission was received.
What is the product code of K203513?
The FDA product code is NGX – Stimulator, Muscle, Powered, For Muscle Conditioning, a Class II (moderate risk) device regulated under 21 CFR 890.5850.