FDA UDI
In Commercial Distribution
🇺🇸 United States
Nerve Reviver
DI: 00860011592815
·
Model: Neurowave
·
Protocol Solutions LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nerve Reviver
- Primary DI
- 00860011592815
- Version / Model
- Neurowave
- Company Name
- Protocol Solutions LLC
- Labeler DUNS
- 128815621
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-17
- Public Version
- 1
- Public Version Date
- 2025-09-25
- Public Version Status
- New
- Public Device Record Key
- aa89d1ab-89d4-467c-a0d0-dc56ff95e107
Device Description
Infrared therapeutic heating device marketed under the Nerve Reviver brand. Neurowave model provides non-invasive infrared light therapy intended for temporary relief of minor muscle and joint pain, stiffness, and increased local circulation.
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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62202 | Blue/red/infrared phototherapy lamp | A portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860011592815 | GS1 |
Customer Contacts
- Phone
- 417-593-7725
- [email protected]