CHOICEMMED AMERICA CORPORATION

FDA Device Registration & Listing · Bristol, PA, US · Registration 3008507279

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008507279
FEI Number
3008507279
Entity Name
CHOICEMMED AMERICA CORPORATION
City/State/Country
Bristol, PA, US
Establishment Address
2550 PEARL BUCK RD STE 8A, Bristol, PA 19007, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
ChoiceMMed America Corporation (Owner Number: 10043975)
Owner / Operator Contact Address
2550 Pearl Buck Road, Suite 8A, Bristol, PA 19007, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K160508
PMA Number
N/A

All Registered Proprietary Names

Electronic Pulse Stimulator MDTS111 Electronic Pulse Stimulator MDTS116 Wireless Blood Pressure Monitor Oximeter, Pulse Oximeter, Fingertip Pulse Oximeter Digital Thermometer MT-118

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2019-12-05
NYN Stimulator, Electrical, Transcutaneous, For Arthritis Neurology Class 2 882.5890 2019-12-05
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2019-12-05
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2019-12-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-02-08
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-09-28
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2026-05-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-12-03
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2014-04-25
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2014-04-25
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-09-28
ION Exerciser, Non-Measuring Physical Medicine Class 1 890.5370 2021-06-23
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-12-03
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2019-12-02
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2019-12-02
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2016-08-08
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-12-04
OCH Oximeter, Infrared, Sporting, Aviation Cardiovascular Class 2 870.2700 2013-04-12
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2019-11-29
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-04-15
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2026-05-06
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2019-12-03
PGJ Oximeter, Wellness Cardiovascular Class 2 870.2700 2026-05-06
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2019-12-05

Official Correspondent

Paul Gao

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ChoiceMMed America Corporation
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
K221200 Xbody Hungary Kft. XBody Go USA, XBody Pro USA 2023-01-31
K881862 Thermo Body Wrap Systems, Inc. THERMO-BODY-WRAP SYSTEM 1988-10-13
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

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.

Similar Registrations

Registration Number Establishment Name Location
3015282440 MEDICAL CABLES S.L. Malaga, ES
3015781781 WIEMSPRO S.L Malaga, ES
3029924973 SHENZHEN SINREL TECH LTD Shenzhen Guangdong, CN
3013889849 Expeditors International of Washington, Inc. Salt Lake City, UT, US
3044675848 PEPPER INTERACTIVE INC Wilmington, DE, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008507279. Last updated year: 2026. Please use registration number 3008507279 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.