FDA Registration
Active
🇺🇸 United States
THE PROMETHEUS GROUP
Reg #: 1224842
·
FEI: 1000513601
·
Expires 2026
Products
7
Proprietary Names
6
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- THE PROMETHEUS GROUP
- Registration Number
- 1224842
- FEI Number
- 1000513601
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1 WASHINGTON ST., SUITE 3171
- City
- DOVER
- State
- NH
- ZIP
- 03820
- Country
- US
Regulatory Submissions
- 510(k) Number
- K993976
Owner / Operator
- Firm Name
- THE PROMETHEUS GROUP
- Operator Number
- 9021632
- Address
- 1 WASHINGTON ST., SUITE 3171
- City
- Dover
- State
- NH
- Postal Code
- 03820
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Class 2 | Gastroenterology, Urology | No | 2007-10-09 |
| Perineometer | HIR | Class 2 | Obstetrics/Gynecology | No | 2007-10-09 |
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2010-12-29 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2019-12-17 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2016-04-18 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2016-04-18 |
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 2007-07-10 |
Proprietary Names
Pathway Vaginal/Rectal Perineometer Probe
Pathway TR-10, TR-10C, TR-20, TR-20C
Pathway STM-10 Pelvic Floor Stimulator
Synergy Plus
VARIOUS MODELS OF SUR
Pathway MR-10, MR-15, MR-20, MR-25
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device