FDA Registration
Active
🇺🇸 United States
Replexa+
Reg #: 3007134923
·
FEI: 3007134923
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PROMEDTEK, INC.
- Registration Number
- 3007134923
- FEI Number
- 3007134923
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15475 N Greenway Hayden Loop Ste 21-22b
- City
- Scottsdale
- State
- AZ
- ZIP
- 85260
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162240
Owner / Operator
- Firm Name
- ProMedTek, Inc.
- Operator Number
- 10026515
- Address
- 4110 N Scottsdale Road, Suite 270
- City
- Scottsdale
- State
- AZ
- Postal Code
- 85251
- Country
- US
- Correspondent
- Daniel Puchek
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | IMJ | Class 2 | Physical Medicine | No | 2016-12-26 |
Proprietary Names
Replexa+
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility