FDA Registration
Active
🇺🇸 United States
PIVOTAL HEALTH SOLUTIONS
Reg #: 3007278668
·
FEI: 3007278668
·
Expires 2026
Products
13
Proprietary Names
3
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- PIVOTAL HEALTH SOLUTIONS
- Registration Number
- 3007278668
- FEI Number
- 3007278668
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3003 9th Ave. SW
- City
- Watertown
- State
- SD
- ZIP
- 57201
- Country
- US
Regulatory Submissions
- 510(k) Number
- K060134
Owner / Operator
- Firm Name
- Pivotal Health Solutions, Inc.
- Operator Number
- 10030456
- Address
- 3003 9th Ave SW
- City
- Watertown
- State
- SD
- Postal Code
- 57201
- Country
- US
- Correspondent
- Julee L Driver
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bars, Parallel, Exercise | IOE | Class 1 | Physical Medicine | No | 2021-08-26 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2011-01-11 |
| Chair And Table, Medical | KMN | Class 1 | General Hospital | No | 2020-09-14 |
| Table, Powered | INQ | Class 1 | Physical Medicine | No | 2009-10-06 |
| Bars, Parallel, Powered | IRR | Class 1 | Physical Medicine | No | 2024-12-17 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2013-12-10 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2019-06-27 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2011-10-05 |
| Equipment, Traction, Powered | ITH | Class 2 | Physical Medicine | No | 2010-11-24 |
| Accessories, Traction | ILZ | Class 1 | Physical Medicine | No | 2016-12-07 |
| Head Halter, Traction | IRS | Class 1 | Physical Medicine | No | 2016-12-07 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2009-11-10 |
| Table, Mechanical | INW | Class 1 | Physical Medicine | No | 2009-10-06 |
Proprietary Names
Parallel bars
Portable Parallel Bars
Electric Parallel Bars
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device