K233035 is an FDA 510(k) clearance for the Electronic Muscle Stimulator (Model MP01). This device is classified as a Stimulator, Muscle, Powered, For Muscle Conditioning (Class II - Special Controls, product code NGX).
Submitted by Shenzhen Hengbosi Industrial Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 8, 2024, 105 days after receiving the submission on September 25, 2023.
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 | K233035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2023 |
| Decision Date | January 08, 2024 |
| Days to Decision | 105 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. |