Identity
- Trade Name
- EMSI 1.75 x 1.75 4 pack Samples FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Model / Reference
- SRELEC0016 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858688006902 FDA UDI
- 510(k) Number
- K050788 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
EMSI 1.75 x 1.75 4 pack Samples by Emsi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K050788 also covers:
- 25R(4)H-Samples — Emsi
- 40(16)HD — Emsi
- 50R(4)H-Sample — Emsi
- 50x50(4)H-Samples — Emsi
- 50x90(4)H-Samples — Emsi
- 75R(4)H-Samples — Emsi
- EMSI 4 x 7 Dispersive Pad — Emsi
- EMSI 40 x 40 Electrical Stimulation Electrode 24 pack — Emsi
- EMSI 40 x 40 Electrical Stimulation Electrode 4 pack — Emsi
- EMSI 40 x 40 Electrode — Emsi
- EMSI 45 x 45 Electrical Stimulation Electrode — Emsi
- EMSI 45 x 45 Electrode 4 pack — Emsi
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
- Emsi
Sources (1)
- FDA UDI 39936e4d-18c1-4531-99db-4aa45ef65755 34 fields · synced Jun 8, 2026