ProActive Alevia 2 in 1 TENS
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Basic Information
- Brand Name
- ProActive Alevia 2 in 1 TENS
- Primary DI
- 00775757154251
- Version / Model
- 715-425
- Catalog Number
- 715-425
- Company Name
- A.M.G. Médicale Inc
- Labeler DUNS
- 207372814
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-12
- Public Version
- 1
- Public Version Date
- 2023-06-20
- Public Version Status
- New
- Public Device Record Key
- 6895a91f-5d72-47e6-a22e-9a1d7587ff00
Device Description
The TENS 2-in-1 Physiotherapy Alevia™ by ProActive™ is a 2-in-1 (TENS and EMS) device that gives you the ability to fully customize treatment options or choose one of the 18 pre-set programs. It has a large, easy-to-read LCD and includes all accessories. The Alevia™ comes complete with 4 self-adhesive, pre-gelled and reusable electrodes, one rechargeable battery with USB Cable, lead wires, instructions and a storage bag. ProActive™ offers a complete line of physiotherapy devices, clinically proven to relieve pain without drugs, including a full line-up of electrodes. The Alevia™ Dual channel TENS Electro-Stimulator relieves pain in 2 ways: TENS (Transcutaneous Nerve Stimulation) stimulates or numbs nerves EMS (Electrical Muscle Stimulation) prevents atrophy
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35372 | Analgesic transcutaneous electrical nerve stimulation system | An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00775757154251 | GS1 | ||||
| Package | 00057565994664 | GS1 | Master Case | 6 | In Commercial Distribution |