Identity
- Trade Name
- The Electrode Store FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- Ear Clip Electrodes, 9.5mm Pure Silver Discs (pair), 1.5 mm socket FDA UDI
- Model / Reference
- IME-SAF FDA UDI
- Description
- Ear Clip Electrodes, 9.5mm Pure Silver Discs (pair), 1.5 mm socket FDA UDI
Identifiers
- Catalog Number
- IME-SAF FDA UDI
- Primary DI / UDI-DI
- 00816022021813 FDA UDI
- 510(k) Number
- K022197 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Analytical non-scalp cutaneous electrode 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Analytical non-scalp cutaneous electrode
The Electrode Store by Impulse Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K022197 also covers:
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, 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
- Impulse Medical Technologies, Inc.
Sources (1)
- FDA UDI 0f911923-0509-49d3-882e-37230790a9ee 35 fields · synced Jun 7, 2026