FDA UDI
In Commercial Distribution
🇺🇸 United States
Prelivia
DI: 17540176050091
·
Model: PR-IES1A
·
Rehabtronics Inc
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Prelivia
- Primary DI
- 17540176050091
- Version / Model
- PR-IES1A
- Company Name
- Rehabtronics Inc
- Labeler DUNS
- 243936569
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-12
- Public Version
- 1
- Public Version Date
- 2024-11-20
- Public Version Status
- New
- Public Device Record Key
- a326fa67-f8e6-436b-b69d-ca3e07978f42
Device Description
The Prelivia System is a portable transcutaneous muscle stimulation system intended to increase regional blood circulation at stimulated treatment areas, and to reduce the incidence and progression of pressure ulcers (bed sores) in individuals who are immobile due to their clinical condition.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35995 | Transcutaneous electrical stimulation electrode, single-use | An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device. | No | Active |
| 46573 | Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 17540176050091 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210979 | 000 |