Portable Neuromodulation Stimulator (PoNS)
K-번호: K253061 · 2026-05-13
광고
기기 요약
Portable Neuromodulation Stimulator (PoNS) is the device name listed in this FDA 510(k) record. The listed applicant is Helius Medical, Inc.. It received FDA 510(k) clearance on 2026-05-13 under 510(k) number K253061. The device is classified under product code QCF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
자주 묻는 질문
What is the Portable Neuromodulation Stimulator (PoNS)?
Portable Neuromodulation Stimulator (PoNS) is a medical device that received FDA 510(k) clearance on 2026-05-13. The listed applicant is Helius Medical, Inc.. The 510(k) number is K253061.
When did Portable Neuromodulation Stimulator (PoNS) receive FDA 510(k) clearance?
Portable Neuromodulation Stimulator (PoNS) received FDA 510(k) clearance on 2026-05-13, under 510(k) number K253061.
Who is the listed applicant for Portable Neuromodulation Stimulator (PoNS)?
The FDA 510(k) record lists Helius Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Portable Neuromodulation Stimulator (PoNS)?
The FDA product code for Portable Neuromodulation Stimulator (PoNS) is QCF.
관련 임상시험
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751의료 기기 인공지능 보조 유로-캠 캐터터 평가 시스템:膀胱癌 진단을 위한NOT_YET_RECRUITING
공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.
광고