FDA Registration
Active
🇺🇸 United States
CHOICEMMED AMERICA CORPORATION
Reg #: 3008507279
·
FEI: 3008507279
·
Expires 2026
Products
12
Proprietary Names
5
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- CHOICEMMED AMERICA CORPORATION
- Registration Number
- 3008507279
- FEI Number
- 3008507279
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2550 PEARL BUCK RD STE 8A
- City
- Bristol
- State
- PA
- ZIP
- 19007
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162517
Owner / Operator
- Firm Name
- ChoiceMMed America Corporation
- Operator Number
- 10043975
- Address
- 2550 Pearl Buck Road, Suite 8A
- City
- Bristol
- State
- PA
- Postal Code
- 19007
- Country
- US
- Correspondent
- Paul Gao
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2019-12-05 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2019-12-05 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2019-12-05 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2019-12-05 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2021-02-08 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2021-06-23 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2019-12-04 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2013-04-12 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2026-05-06 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2019-12-03 |
| Oximeter, Wellness | PGJ | Class 2 | Cardiovascular | No | 2026-05-06 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2026-01-13 |
Proprietary Names
Electronic Pulse Stimulator MDTS111
Electronic Pulse Stimulator MDTS116
Wireless Blood Pressure Monitor
Oximeter, Pulse Oximeter, Fingertip Pulse Oximeter
Digital Thermometer MT-118
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198