FDA UDI
In Commercial Distribution
🇺🇸 United States
Quell Fibromyalgia
DI: 00851221006513
·
Model: QE-NBK-RBL
·
NeuroMetrix, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Quell Fibromyalgia
- Primary DI
- 00851221006513
- Version / Model
- QE-NBK-RBL
- Company Name
- NeuroMetrix, Inc.
- Labeler DUNS
- 957536014
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-01
- Public Version
- 2
- Public Version Date
- 2026-01-12
- Public Version Status
- Update
- Public Device Record Key
- 944b4160-ad13-47c5-993f-70ca6a9e7fbd
Device Description
Standard Band for 2.0 Device
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| QSQ | Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms | Neurology | 882.5888 | 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 | 00851221006513 | GS1 |
Customer Contacts
- Phone
- 1-888-903-2673
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN210046 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius