FDA UDI
In Commercial Distribution
🇺🇸 United States
1BYONE
DI: 00858069007009
·
Model: 725EU-0003
·
1BYONEPRODUCTS INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- 1BYONE
- Primary DI
- 00858069007009
- Version / Model
- 725EU-0003
- Company Name
- 1BYONEPRODUCTS INC.
- Labeler DUNS
- 845019202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-24
- Public Version
- 5
- Public Version Date
- 2022-03-14
- Public Version Status
- Update
- Public Device Record Key
- c0e96bd7-629f-4c12-88d1-fb2b7243645d
Device Description
Electronic Pulse Stimulator Replacement Pads set of 3
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|---|---|
| Package | 10863696000399 | GS1 | outer carton | 120 | In Commercial Distribution | |
| Package | 00863696000392 | GS1 | gift box | 3 | In Commercial Distribution | |
| Primary | 00858069007009 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153520 | 000 |