Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Perin Health System (PHD80060-2)

K-Number: K252984 · 2026-01-22

ApplicantPerin Health Devices, LLC
Decision Date2026-01-22
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Perin Health System (PHD80060-2) is a medical device manufactured by Perin Health Devices, LLC. It received FDA 510(k) clearance on 2026-01-22 under approval number K252984. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Perin Health System (PHD80060-2)?

Perin Health System (PHD80060-2) is a medical device that received FDA 510(k) clearance on 2026-01-22. It is manufactured by Perin Health Devices, LLC. The 510(k) number is K252984.

When was Perin Health System (PHD80060-2) approved by the FDA?

Perin Health System (PHD80060-2) received FDA 510(k) clearance on 2026-01-22, under approval number K252984.

What company makes Perin Health System (PHD80060-2)?

Perin Health System (PHD80060-2) is manufactured by Perin Health Devices, LLC.

What is the FDA product code for Perin Health System (PHD80060-2)?

The FDA product code for Perin Health System (PHD80060-2) is DRG.

Related Clinical Trials

NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT07544654 DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy NOT_YET_RECRUITING NCT07607899 Virtual Reality for Pain and Well-Being in Older Adults NOT_YET_RECRUITING NCT02703207 Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD RECRUITING

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026)

Related Devices (Code: DRG)

K161916TelePatch Cardiac MonitorMedicomp, Inc. K153719LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStreamHoneywell Hommed, LLC K163694Rooti Rx ECG Event Recorder, Rooti Link APP SoftwareRooti Labs , Ltd. K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc. K171406Optum TeleHealth ApplicationUnited Health Group, Inc. K171029eCareCoordinatorVisicu, Inc.

Official Source

View on FDA Database →

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

↑