FDA Registration
Active
🇺🇸 United States
Back on Track back brace
Reg #: 3009809406
·
FEI: 3009809406
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BACK ON TRACK BOT LLC
- Registration Number
- 3009809406
- FEI Number
- 3009809406
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 350 Circle of Progress Drive
- City
- Pottstown
- State
- PA
- ZIP
- 19464
- Country
- US
Owner / Operator
- Firm Name
- Back on Track BOT LLC
- Operator Number
- 10046578
- Address
- 350 Circle of Progress Drive
- City
- Pottstown
- State
- PA
- Postal Code
- 19464
- Country
- US
- Correspondent
- James Ruder
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2014-04-09 |
Proprietary Names
Back on Track back brace
Back on Track back brace dual support
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device