FDA UDI
In Commercial Distribution
🇺🇸 United States
BiowavePRO
DI: 00859911006065
·
Model: BWPD01
·
BIOWAVE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BiowavePRO
- Primary DI
- 00859911006065
- Version / Model
- BWPD01
- Company Name
- BIOWAVE CORPORATION
- Labeler DUNS
- 005759084
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 6
- Public Version Date
- 2023-08-07
- Public Version Status
- Update
- Public Device Record Key
- 2a4c34b5-7643-4bf2-9c60-fc67ae204dfc
Device Description
BioWavePRO Neurostimulator
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| NHI | Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60959 | Analgesic PENS system | An assembly of mains electricity (AC-powered) devices intended for the relief of chronic neuropathic pain through percutaneous electrical nerve stimulation (PENS). It typically consists of external current generator, return electrode(s), connection cables and a system probe which may be provided separately. It is intended to deliver controlled electrical impulses directly to the subcutaneous tissue (i.e., invasively) in the vicinity of a peripheral nerve. It is intended to be used by a healthcare professional in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859911006065 | GS1 |
Customer Contacts
- Phone
- 1-877-246-9283
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061166 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius