Identity
- Trade Name
- 1BYONE FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- Electronic Pulse Stimulator Replacement Pads set of 3 FDA UDI
- Model / Reference
- 725EU-0003 FDA UDI
- Description
- Electronic Pulse Stimulator Replacement Pads set of 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858069007009 FDA UDI
- 510(k) Number
- K153520 FDA UDI
- FDA Product Code
- NGX FDA UDI
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 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
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Analgesic transcutaneous electrical nerve stimulation system
1byone by 1byoneproducts Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K153520 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
- 1byoneproducts Inc.
Sources (1)
- FDA UDI c0e96bd7-629f-4c12-88d1-fb2b7243645d 34 fields · synced Jun 8, 2026