FDA 510(k)

PainTB, PainTJ

K-Number: K203337 · 2022-02-11

Decision Date2022-02-11

Product CodeNHN

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

PainTB, PainTJ is the device name listed in this FDA 510(k) record. The listed applicant is Ptech Co., Ltd.. It received FDA 510(k) clearance on 2022-02-11 under 510(k) number K203337. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PainTB, PainTJ?

PainTB, PainTJ is a medical device that received FDA 510(k) clearance on 2022-02-11. The listed applicant is Ptech Co., Ltd.. The 510(k) number is K203337.

When did PainTB, PainTJ receive FDA 510(k) clearance?

PainTB, PainTJ received FDA 510(k) clearance on 2022-02-11, under 510(k) number K203337.

Who is the listed applicant for PainTB, PainTJ?

The FDA 510(k) record lists Ptech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PainTB, PainTJ?

The FDA product code for PainTB, PainTJ is NHN.

Related Devices (Code: NHN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN Laser (Model# EVRL)Erchonia Corporation K252273Therapy USDmc Importação E Exportação DE Equipamentos Ltda K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos Ltda K231409Erchonia FX-405Erchonia Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.