Identity
- Trade Name
- CHATTANOOGA FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- STIMGEL GARMENT ELECTRODES, 1 EA 6 X 3.5" & 2 EA 2.75 X 4" FDA UDI
- Model / Reference
- 199597 FDA UDI
- Description
- STIMGEL GARMENT ELECTRODES, 1 EA 6 X 3.5" & 2 EA 2.75 X 4" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190446153290 FDA UDI
- 510(k) Number
- K130987 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Chattanooga by Djo, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130987 also covers:
- EconoStim — AXELGAARD MANUFACTURING CO., LTD.
- 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
- 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
- Djo, Llc
Sources (1)
- FDA UDI 55a84fcf-498c-4001-91cc-ce944ce86ee3 35 fields · synced May 30, 2026