Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2081040

FEI Number

2081040

Entity Name

Prestige Medical

City/State/Country

Grand Prairie, TX, US

Establishment Address

2750 113th St, Grand Prairie, TX 75050, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Rashman Corp. DBA Prestige Medical (Owner Number: 2081040)

Owner / Operator Contact Address

6320 Canoga Avenue, Suite 101, Woodland Hills, CA 91367, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201384

PMA Number

N/A

All Registered Proprietary Names

82, S82, 79, S79, 882, 80, A2, A1, A121 70 Basic, Standard, Premium Aneroids PM HM-35, HM-30-OB PM DT-30, 32 Infrared Thermometer PM DT-7 Standard Digital Thermometer PM Premium, Basic Aneroids and Kits PM Clinical, Traditional, Basic Stethoscopes PM Clinical, Traditional, Basic, Clearsound Stethoscopes PM Surgical Hammer PM 4200, 4220, 4200-B, 4220-B PM Exam Lights 3430, 200 series, 210 series, 222 series, 214 series, 229 PM Tuning Forks PM HM-55 PM DT-29 Infrared Thermometer PM 459 DX Pulse Oximeter PM Traditional, Premium, Standard, Basic Aneroids and Aneroid Kits PM 452 Pulse Oximeter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2023-11-06
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-01-12
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-01-12
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-01-12
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2023-01-12
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2023-01-12
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-01-12
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2023-01-12
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2023-01-12
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2023-01-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-01-12
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-01-12
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-01-12
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2023-01-12
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-01-27

Official Correspondent

Brian Spangenberg

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Rashman Corp. DBA Prestige Medical

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
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28
K253089	Shenzhen Best Electronics Co., Ltd.	NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)	2026-02-13
K972301	Rudolf Riester GmbH & Co. KG	BIG BEN SQUARE, BIG BEN ROUND	1997-09-17
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

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 2081040. Last updated year: 2026. Please use registration number 2081040 when referencing this establishment in official correspondence.