FDA Registration
Active
🇺🇸 United States
MANAMED LLC
Reg #: 3011767724
·
FEI: 3011767724
·
Expires 2026
Products
26
Proprietary Names
6
Establishment Types
3
Classifications
26
Registration Details
- Registration Name
- MANAMED LLC
- Registration Number
- 3011767724
- FEI Number
- 3011767724
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2612 Sirius Drive
- City
- Denton
- State
- TX
- ZIP
- 76208
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211253
Owner / Operator
- Firm Name
- ManaMed LLC
- Operator Number
- 10049811
- Address
- 2612 Sirius Drive
- City
- Denton
- State
- TX
- Postal Code
- 76208
- Country
- US
- Correspondent
- Trevor Theriot
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2022-06-15 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2015-08-03 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2025-12-23 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2022-06-15 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2025-12-23 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2025-12-23 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2023-09-28 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2021-07-19 |
| Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat | PFW | Class 2 | Physical Medicine | No | 2023-08-17 |
| Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | IMI | Class 2 | Physical Medicine | No | 2023-08-17 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2019-03-07 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2026-05-21 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2022-06-15 |
| Media, Coupling, Ultrasound | MUI | Class 2 | Radiology | No | 2023-08-17 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2024-01-31 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2022-06-15 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2022-06-15 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2023-11-06 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2023-11-06 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2023-11-06 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2023-11-06 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2023-11-06 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2016-10-21 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2019-03-07 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2020-10-13 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2022-06-15 |
Proprietary Names
Belly Band
ManaEZ Crutch Spring
ManaEZ sling Universal
ManaGo 71
PlasmaFlight
PlasmaFlow
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device