Identity
- Trade Name
- EconoStim FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- 2" (5 cm) Round FDA UDI
- Model / Reference
- ESB5000 FDA UDI
- Description
- 2" (5 cm) Round FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851913006203 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-useTranscutaneous electrical stimulation electrode, reusable
EconoStim by Axelgaard Manufacturing Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transcutaneous electrical stimulation electrode, reusable.
- Richmar — South Dakota Partners · Class II
- L300 Go System — Bioness Medical, Inc. · Class II
- HiDow — Hi-Dow International Incorporated · Class II
- Everyway — EVERYWAY MEDICAL INSTRUMENTS CO., LTD. · Class II
- Axion — AXION USA LLC · Class II
- Pain Management — EVERYWAY MEDICAL INSTRUMENTS CO., LTD. · Class II
- Richmar — Clearlake-Tech Inc. · Class II
- ManaFlexx 2 Electrodes - 4 electrodes — MANAMED LLC · Class II
Cleared under the same submission
K130987 also covers:
- 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
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Axelgaard Manufacturing Co., Ltd.
Sources (1)
- FDA UDI fec08edf-0908-4391-9fa0-bb694c873fc7 36 fields · synced May 30, 2026