Identity
- Trade Name
- LSI Silver Self Adhesive, Disposable Electrodes FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- 4 IN OVAL SNAP FDA UDI
- Model / Reference
- 300-159 FDA UDI
- Description
- 4 IN OVAL SNAP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850958007206 FDA UDI
- 510(k) Number
- K050469 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
LSI Silver Self Adhesive, Disposable Electrodes by Compass Health Brands Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K050469 also covers:
- EZ-Stick — COMPASS HEALTH BRANDS CORP.
- EZ-Stick — COMPASS HEALTH BRANDS CORP.
- Karatrode — COMPASS HEALTH BRANDS CORP.
- Karatrode — COMPASS HEALTH BRANDS CORP.
- LSI Silver Self Adhesive, Disposable Electrodes — COMPASS HEALTH BRANDS CORP.
- LSI Silver Self Adhesive, Disposable Electrodes — COMPASS HEALTH BRANDS CORP.
- LSI Silver Self Adhesive, Disposable Electrodes — COMPASS HEALTH BRANDS CORP.
- Medi-Trode Platinum — COMPASS HEALTH BRANDS CORP.
- Medi-Trode Platinum — COMPASS HEALTH BRANDS CORP.
- Medical Science Private Label — COMPASS HEALTH BRANDS CORP.
- MultiStim Electrodes — COMPASS HEALTH BRANDS CORP.
- MultiStim Electrodes — COMPASS HEALTH BRANDS CORP.
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
- Compass Health Brands Corp.
Sources (1)
- FDA UDI 5b05a6cc-6962-4a51-a7ec-3abcf967fdb4 36 fields · synced May 30, 2026