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1byone

FDA UDI

Class II (US FDA UDI)

by 1byoneproducts Inc.

Identity

Trade Name
1byone FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
Two different size pads, one is 4*4 cm pad ( 4 pieces) one is big pad. ( 1 pieces) FDA UDI
Model / Reference
PL-029K16B-P3 FDA UDI
Description
Two different size pads, one is 4*4 cm pad ( 4 pieces) one is big pad. ( 1 pieces) FDA UDI

Identifiers

Primary DI / UDI-DI
00858069007085 FDA UDI
FDA Product Code
NGX FDA UDI
IRT FDA UDI
NYN FDA UDI
NUH 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
890.5740 FDA UDI
882.5890 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

Yes

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

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
1byoneproducts Inc.

Sources (1)

  • FDA UDI 4a61522a-bee0-4c66-b460-cfe19de295ac 33 fields · synced Jun 6, 2026