Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009518429

FEI Number

3009518429

Entity Name

New Horizon Medical Solutions

City/State/Country

Las Vegas, NV, US

Establishment Address

8395 W Sunset Rd Ste 200, Las Vegas, NV 89113, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

New Horizon Health Care Management (Owner Number: 10095696)

Owner / Operator Contact Address

8395 W Sunset Road, Las Vegas, NV 89113, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191460

PMA Number

N/A

All Registered Proprietary Names

Xpansion Micro-Autografting Kit PWD Platform Wound Dressing PWD Platform Wound Dressing 3" x 5" Oblong

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2026-04-16
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2026-04-16
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2026-04-15

Official Correspondent

William Hall

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

New Horizon Health Care Management

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

Similar Registrations

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8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK
3013901429	LONG LIFE SURGICAL INDUSTRIES	Sialkot Punjab, PK
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009518429. Last updated year: 2026. Please use registration number 3009518429 when referencing this establishment in official correspondence.