Identity
- Trade Name
- Calmare Therapeutics, Inc. FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- 0.9" x 1.1" (2.2cm x 2.8cm) Snap Eyelet, White Fabric Top Electrode FDA UDI
- Model / Reference
- CTI3001 FDA UDI
- Description
- 0.9" x 1.1" (2.2cm x 2.8cm) Snap Eyelet, White Fabric Top Electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00861432000323 FDA UDI
- 510(k) Number
- K130987 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
- 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: Transcutaneous electrical stimulation electrode, single-use
Calmare Therapeutics, Inc. by Calmare Therapeutics Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130987 also covers:
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- EconoStim — AXELGAARD MANUFACTURING CO., LTD.
- ValuTrode Lite Foam — AXELGAARD MANUFACTURING CO., LTD.
- ProStim Electrodes — AliMed, LLC
- ProStim Electrodes — AliMed, LLC
- Slendertone Replacement Abdominal Toning Gel Pads — Bio-Medical Research, Ltd.
- The Flex Belt Replacement Electrodes — Bio-Medical Research, Ltd.
- Calmare Therapeutics, Inc. — CALMARE THERAPEUTICS INCORPORATED
- CHATTANOOGA — DJO, LLC
- CHATTANOOGA — DJO, LLC
- COMPEX — DJO, LLC
- COMPEX — DJO, LLC
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
- Calmare Therapeutics Incorporated
Sources (1)
- FDA UDI a7c3c8e1-d44b-4bf0-91b7-57fabbb3768b 36 fields · synced Jun 1, 2026