BTL 799-2
FDA 510(k) K180813 · BTL Industries, Inc.
510(k) numberK180813
Submission
- Device name
- BTL 799-2
- Applicant
- BTL Industries, Inc.
Marlborough, MA, US - Received
- March 29, 2018
- Decision date
- June 14, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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Questions and answers
When was BTL 799-2 cleared by the FDA?
BTL 799-2 (K180813) received a 510(k) decision of Substantially Equivalent on June 14, 2018, 77 days after the submission was received.
What is the product code of K180813?
The FDA product code is NGX – Stimulator, Muscle, Powered, For Muscle Conditioning, a Class II (moderate risk) device regulated under 21 CFR 890.5850.