K191938 is an FDA 510(k) clearance for the FitRelief TENS&EMS Wireless Device. This device is classified as a Stimulator, Muscle, Powered, For Muscle Conditioning (Class II - Special Controls, product code NGX).
Submitted by Heat IN A Click, LLC (Dania, US). The FDA issued a Cleared decision on August 28, 2020, 406 days after receiving the submission on July 19, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.5850. 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 Device Is Not Intended For Use In Patients With Medical Conditions And Is Intended Only For Muscle Conditioning Purposes..
| 510(k) Number | K191938 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2019 |
| Decision Date | August 28, 2020 |
| Days to Decision | 406 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | NGX - Stimulator, Muscle, Powered, For Muscle Conditioning |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |
| Definition | 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 Device Is Not Intended For Use In Patients With Medical Conditions And Is Intended Only For Muscle Conditioning Purposes. |