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FDA 510(k)

ACTIV.A.C. Therapy Unit

K-Number: K183543 · 2019-03-20

ApplicantKci USA, Inc.
Decision Date2019-03-20
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACTIV.A.C. Therapy Unit is a medical device manufactured by Kci USA, Inc.. It received FDA 510(k) clearance on 2019-03-20 under approval number K183543. 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 ACTIV.A.C. Therapy Unit?

ACTIV.A.C. Therapy Unit is a medical device that received FDA 510(k) clearance on 2019-03-20. It is manufactured by Kci USA, Inc.. The 510(k) number is K183543.

When was ACTIV.A.C. Therapy Unit approved by the FDA?

ACTIV.A.C. Therapy Unit received FDA 510(k) clearance on 2019-03-20, under approval number K183543.

What company makes ACTIV.A.C. Therapy Unit?

ACTIV.A.C. Therapy Unit is manufactured by Kci USA, Inc..

What is the FDA product code for ACTIV.A.C. Therapy Unit?

The FDA product code for ACTIV.A.C. Therapy Unit is OMP.

Other Devices by Kci USA, Inc.

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit K190697PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)

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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.

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