Identity
- Trade Name
- TONE-A-MATIC FDA UDI
- Generic Name
- Electrode/transducer strap, reusable FDA UDI
- Device Name
- Garment Electrodes FDA UDI
- Model / Reference
- Model A: Direct Connect Ab & Back Fabric Belt FDA UDI
- Description
- Garment Electrodes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06278437251072 FDA UDI
- 510(k) Number
- K222863 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Electrode/transducer strap, reusable 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrode/transducer strap, reusable
Tone-A-Matic by Tone-A-Matic International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K222863 also covers:
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
- Tone-A-Matic International, Inc.
Sources (1)
- FDA UDI f4802feb-ae91-4956-8626-a76df38f8444 34 fields · synced May 30, 2026