K250146 is an FDA 510(k) clearance for the SofWave System. This device is classified as a Stimulator, Muscle, Powered, For Muscle Conditioning (Class II - Special Controls, product code NGX).
Submitted by Sofwave Medical, Ltd. (Yokneam Iiit, IL). The FDA issued a Cleared decision on April 18, 2025, 87 days after receiving the submission on January 21, 2025.
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 | K250146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2025 |
| Decision Date | April 18, 2025 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| 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. |