Skip to the page
Get started – free

Data / Medical devices / United States / Prime Med Shop LLC

Prime Med Shop LLC: FDA-registered device maker in Stafford, TX, United States, 6 510(k) clearances

Prime Med Shop LLC is registered with the FDA (registration 3013545943) in Stafford, TX, United States. It lists 28 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 13, 2020. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Prime Med Shop LLC
FDA registration number
3013545943
Address
10749 Cash Road, Stafford, TX, United States, 77477
Owner or operator
Prime Med Shop LLC (10054629)
Roles
Complaint file establishment
First device listed
April 10, 2017
Registered through
2026
Brand names listed
Bath Tub Handle, Bed assist rail, Coccyx Cushion, Daily assist device, Sock aid, Eggcrate mattress pad, Folding Cane, Knee Pillow, Lumbar back support pillow and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, WheelchairKNO1Complaint file establishmentaccessdata.fda.gov
Adaptor, DressingILD1Complaint file establishmentaccessdata.fda.gov
Adaptor, HygieneILS1Complaint file establishmentaccessdata.fda.gov
Adult Portable Bed Rails For Medical PurposesQTC1Complaint file establishmentaccessdata.fda.gov
Aid, TransferIKX1Complaint file establishmentaccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Complaint file establishmentaccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Complaint file establishmentaccessdata.fda.gov
Bed, ManualFNJ1Complaint file establishmentaccessdata.fda.gov
Cane, Safety WalkKHY1Complaint file establishmentaccessdata.fda.gov
Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, OsmolalityJMZ1Complaint file establishmentaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Complaint file establishmentaccessdata.fda.gov
Cushion, FlotationKIC1Complaint file establishmentaccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Complaint file establishmentaccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Complaint file establishmentaccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Complaint file establishmentaccessdata.fda.gov
Exerciser, Non-Measuring For Stroke RehabilitationPKS1Complaint file establishmentaccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Complaint file establishmentaccessdata.fda.gov
Mattress, Air Flotation, Alternating PressureFNM2Complaint file establishmentaccessdata.fda.gov
Mattress, Flotation Therapy, Non-PoweredIKY1Complaint file establishmentaccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Complaint file establishmentaccessdata.fda.gov
Orthosis, LumbarIQE1Complaint file establishmentaccessdata.fda.gov
OximeterDQA2Complaint file establishmentaccessdata.fda.gov
Oximeter, Infrared, Sporting, AviationOCH2Complaint file establishmentaccessdata.fda.gov
Solution, Copper Sulfate For Specific Gravity DeterminationsKSL1Complaint file establishmentaccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Complaint file establishmentaccessdata.fda.gov
Table, MechanicalINW1Complaint file establishmentaccessdata.fda.gov
Test, Urine LeukocyteLJX1Complaint file establishmentaccessdata.fda.gov
Walker, MechanicalITJ1Complaint file establishmentaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 13, 2020K191829Microlife Non-Contact Infrared Forehead ThermometerFLLSubstantially EquivalentMicrolife Intellectual Property GmbHaccessdata.fda.gov
July 16, 2019K183663Microlife Digital Infrared Ear ThermometerFLLSubstantially EquivalentMicrolife Intellectual Property GmbHaccessdata.fda.gov
October 29, 2018K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerFLLSubstantially EquivalentJoytech Healthcare Co. , Ltd.accessdata.fda.gov
October 5, 2016K161560Fingertip Pulse Oximeter MD300CN310DQASubstantially EquivalentBeijing Choice Electronic Technology Co., Ltd.accessdata.fda.gov
November 12, 2013K131243NON-CONTACT INFRARED THERMOMETERFLLSubstantially EquivalentShenzhen Jumper Medical Equipment Co., Ltd.accessdata.fda.gov
September 11, 2006K061471MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PCDXNSubstantially EquivalentMicrolife Intellectual Property GmbHaccessdata.fda.gov

Compare with other makers

Updated February 13, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.