K201845 is an FDA 510(k) clearance for the Portable Electro-Stimulation Therapy Device, Model: LGT-232(US). This device is classified as a Stimulator, Muscle, Powered, For Muscle Conditioning (Class II - Special Controls, product code NGX).
Submitted by Guangzhou Longest Science & Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on October 8, 2020, 94 days after receiving the submission on July 6, 2020.
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 | K201845 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2020 |
| Decision Date | October 08, 2020 |
| Days to Decision | 94 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. |