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)

Negative Pressure Wound Therapy Device (V-Move, V-Grand)

K-Number: K241023 · 2024-08-19

ApplicantMed Way, Inc.
Decision Date2024-08-19
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Negative Pressure Wound Therapy Device (V-Move, V-Grand) is a medical device manufactured by Med Way, Inc.. It received FDA 510(k) clearance on 2024-08-19 under approval number K241023. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Negative Pressure Wound Therapy Device (V-Move, V-Grand)?

Negative Pressure Wound Therapy Device (V-Move, V-Grand) is a medical device that received FDA 510(k) clearance on 2024-08-19. It is manufactured by Med Way, Inc.. The 510(k) number is K241023.

When was Negative Pressure Wound Therapy Device (V-Move, V-Grand) approved by the FDA?

Negative Pressure Wound Therapy Device (V-Move, V-Grand) received FDA 510(k) clearance on 2024-08-19, under approval number K241023.

What company makes Negative Pressure Wound Therapy Device (V-Move, V-Grand)?

Negative Pressure Wound Therapy Device (V-Move, V-Grand) is manufactured by Med Way, Inc..

What is the FDA product code for Negative Pressure Wound Therapy Device (V-Move, V-Grand)?

The FDA product code for Negative Pressure Wound Therapy Device (V-Move, V-Grand) is OMP.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT07372677 Pocket-X Gel Non-surgical Periodontal Therapy RECRUITING NCT07613762 High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation. NOT_YET_RECRUITING NCT07235592 PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group RECRUITING NCT07099092 Causal Mechanisms of Odor-Guided Behavior in Humans NOT_YET_RECRUITING NCT07614373 Virtual Reality-based Mindfulness Training for Mental Health After Stroke NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 41072144 Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices. Computers in biology and medicine (2025) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025)

Related Devices (Code: OMP)

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyMedela AG K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC

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.

↑