PainTB, PainTJ— 510(k) K203337

Substantially Equivalent

Ptech Co., Ltd.

FDA 510(k) clearance K203337 for PainTB, PainTJ, Substantially Equivalent on 2022-02-11. Applicant: Ptech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ptech Co., Ltd.
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2020-11-12
Decision date: 2022-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyeongtaek-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.