K232982 is an FDA 510(k) clearance for the EMS Sculpt Machine. This device is classified as a Stimulator, Muscle, Powered, For Muscle Conditioning (Class II - Special Controls, product code NGX).
Submitted by Shandong Huamei Technology Co., Ltd. (Wei Fang, CN). The FDA issued a Cleared decision on November 25, 2024, 430 days after receiving the submission on September 22, 2023.
This device falls under the Physical Medicine 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 | K232982 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2023 |
| Decision Date | November 25, 2024 |
| Days to Decision | 430 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| 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. |