Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009327812

FEI Number

3009327812

Entity Name

Proactive Medical Products

City/State/Country

Mount Vernon, NY, US

Establishment Address

590 Franklin Ave, Mount Vernon, NY 10550, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

PROACTIVE MEDICAL PRODUCTS LLC (Owner Number: 10039097)

Owner / Operator Contact Address

590 Franklin Avenue, Mount Vernon, NY 10550, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Protekt Aire Protekt BP Protekt Finger Pulse Ox Protekt Manual Bed transfer Protekt Overbed Table Protekt Nebulizer Protekt Heel Gel Elevation Boot antitipper Protekt Finger Pulse Ox Protekt IV Pole Protekt Lift, Protekt Stand, Protekt Take A Long, Protekt Dash, Protekt Onyx, Protekt Sling (patient sling) Protekt Finger Pulse Ox footrest Protekt Mask 3 Ply Protekt Regulator Protopia Long Term Care Electric Bed Pro Temp Infrared Non-Contact Thermometer Protekt VX9000 Vital Signs Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2015-05-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-09-04
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2023-01-19
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2019-06-21
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2019-04-22
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2019-06-21
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2024-10-28
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2023-07-28
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2015-05-01
IPR	Crutch	Physical Medicine	Class 1	890.3150	2019-04-22
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	2019-04-22
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2019-04-01
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-03-20
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2019-06-21
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2020-02-24
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-05-05
IMM	Footrest, Wheelchair	Physical Medicine	Class 1	890.3920	2019-04-22
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-26
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2021-03-24
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2019-06-21
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2016-11-30
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2026-01-19
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	2019-04-22
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2019-04-22
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2019-04-22

Official Correspondent

Yossi Light

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PROACTIVE MEDICAL PRODUCTS LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009327812. Last updated year: 2026. Please use registration number 3009327812 when referencing this establishment in official correspondence.