TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)— 510(k) K250360

Name: FDA 510(k) clearance K250360
Creator: U.S. Food and Drug Administration
Published: 2025-05-11

Substantially Equivalent

Shenzhen Jiantuo Electronics Co., Ltd.

FDA 510(k) clearance K250360 for TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026), Substantially Equivalent on 2025-05-11. Applicant: Shenzhen Jiantuo Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Jiantuo Electronics Co., Ltd.
Product code: Code NUH
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2025-02-10
Decision date: 2025-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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