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Data / Medical devices / United States / Choicemmed America Corporation

Choicemmed America Corporation: FDA-registered device maker in Bristol, PA, United States, 17 510(k) clearances

Choicemmed America Corporation is registered with the FDA (registration 3008507279) in Bristol, PA, United States. It lists 12 device types. The FDA files 17 510(k) clearances under its listings, the newest dated December 16, 2025. Registered through 2027. FDA data exported November 3, 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 Choicemmed America Corporation
FDA registration number
3008507279
Address
2550 Pearl Buck RD Ste 8a, Bristol, PA, United States, 19007
Owner or operator
ChoiceMMed America Corporation (10043975)
Roles
Complaint file establishment, Repackager or relabeler
First device listed
April 12, 2013
Registered through
2027
Brand names listed
Digital Thermometer MT-118, Electronic Pulse Stimulator MDTS111, Electronic Pulse Stimulator MDTS116, Oximeter, Pulse Oximeter, Fingertip Pulse Oximeter, Wireless Blood Pressure Monitor

Devices it lists

DeviceProduct codeClassRoleSource
Bottle, Collection, VacuumKDQ2Repackager or relabeleraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Repackager or relabeleraccessdata.fda.gov
Electrode, CutaneousGXY2Repackager or relabeleraccessdata.fda.gov
Exerciser, Non-MeasuringION1Repackager or relabeleraccessdata.fda.gov
Generator, Oxygen, PortableCAW2Repackager or relabeleraccessdata.fda.gov
Oximeter, Infrared, Sporting, AviationOCH2Repackager or relabeleraccessdata.fda.gov
Oximeter, WellnessPGJ2Repackager or relabeleraccessdata.fda.gov
Pad, Heating, PoweredIRT2Repackager or relabeleraccessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For ArthritisNYN2Repackager or relabeleraccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Repackager or relabeleraccessdata.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
December 16, 2025K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)CAWSubstantially EquivalentShenzhen Harveymed Technology Co., Ltd.accessdata.fda.gov
October 21, 2022K221992Electronic Pulse StimulatorNUHSubstantially EquivalentBeijing Choice Electronic Technology Co., Ltd.accessdata.fda.gov
March 1, 2022K213189Wrist-type Fully Automatic Digital Blood Pressure MonitorDXNSubstantially EquivalentJoytech Healthcare Co. , Ltd.accessdata.fda.gov
July 12, 2020K193627Automatic Upper Arm Blood Pressure MonitorDXNSubstantially EquivalentDongguan E-Test Technology Co., Ltd.accessdata.fda.gov
July 29, 2019K190886Non-invasive blood pressure measurement systemsDXNSubstantially EquivalentJoytech Healthcare Co. , Ltd.accessdata.fda.gov
August 29, 2018K181104Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm StyleDXNSubstantially EquivalentShenzhen Combei Technology Co., Ltd.accessdata.fda.gov
June 18, 2018K172895AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819DXNSubstantially EquivalentAgeless Health Industrial Co., Ltd.accessdata.fda.gov
January 10, 2018K171833Digital Blood Pressure Monitor-Wrist StyleDXNSubstantially EquivalentShenzhen Combei Technology Co., Ltd.accessdata.fda.gov
April 14, 2017K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13NUHSubstantially EquivalentJkh Health Co., Ltd.accessdata.fda.gov
November 21, 2016K160508Electronic Pulse StimulatorNUHSubstantially EquivalentBeijing Choice Electronic Technololgy Co., Ltd.accessdata.fda.gov
August 24, 2016K160802Infrared Forehead Thermometer, FT-100AFLLSubstantially EquivalentHangzhou Universal Electronic Co., Ltd.accessdata.fda.gov
June 1, 2016K153552AGE Automatic Upper Arm Blood Pressure MonitorDXNSubstantially EquivalentAgeless Health Industrial Co., Ltd.accessdata.fda.gov
November 22, 2013K132588ADHESIVE ELECTRODESGXYSubstantially EquivalentTop-Rank Health Care Equipment Co., Ltd.accessdata.fda.gov
November 15, 2013K131921ELECTRONIC PULSE STIMULATORNUHSubstantially EquivalentShenzhen Jingkehui Electronic Co.., Ltd.accessdata.fda.gov
June 19, 2013K131395TRANSTEK BLOOD PRESSURE MONITORDXNSubstantially EquivalentGuangdong Transtek Medical Electronics Co., Ltd.accessdata.fda.gov
May 10, 2013K121719SM TENS & PMSNGXSubstantially EquivalentHong Qiangxing (Shenzhen) Electronics Limitedaccessdata.fda.gov
September 8, 2004K041516DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9FLLSubstantially EquivalentVega Technologies, Inc.accessdata.fda.gov

Compare with other makers

Updated December 16, 2025. 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.