Identity
- Trade Name
- QUELL FDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- QUELL Sport Electrode FDA UDI
- Model / Reference
- QE-P02 FDA UDI
- Description
- QUELL Sport Electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851221006049 FDA UDI
- 510(k) Number
- K140586 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Electrode conductive medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrode conductive medium
Quell by Neurometrix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K140586 also covers:
- QUELL — NEUROMETRIX, INC.
- QUELL — NEUROMETRIX, INC.
- QUELL FIBROMYALGIA — NEUROMETRIX, INC.
- QUELL FIBROMYALGIA — NEUROMETRIX, INC.
- QUELL FIBROMYALGIA — NEUROMETRIX, INC.
- QUELL FIBROMYALGIA — NEUROMETRIX, INC.
- QUELL FIBROMYALGIA — NEUROMETRIX, INC.
- QUELL FIBROMYALGIA — NEUROMETRIX, INC.
- Quell Electrode — NEUROMETRIX, INC.
- Quell Electrode — NEUROMETRIX, INC.
- Quell Fibromyalgia — NEUROMETRIX, INC.
- Quell Fibromyalgia — NEUROMETRIX, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Neurometrix, Inc.
Sources (1)
- FDA UDI 096495fe-5deb-4406-b11d-7a5d8184bca0 36 fields · synced Jun 8, 2026