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Dolphin Neurostim

FDA UDI

Class II (US FDA UDI)

by Center For Pain and Stress Research Ltd

Identity

Trade Name
Dolphin Neurostim FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
The Dolphin Neurostim Classic is the latest and most scientifically advanced point stimulator on the market. Features an easy-to-use point locator and 600% more power than leading our competitors. Dolphin Point stimulation may be applied with either left or right hands or using an extension probe, grounding pads, or ear clips. Other standard accessories include a 9-volt battery, carrying case, and instruction manual. FDA UDI
Model / Reference
Classic FDA UDI
Description
The Dolphin Neurostim Classic is the latest and most scientifically advanced point stimulator on the market. Features an easy-to-use point locator and 600% more power than leading our competitors. Dolphin Point stimulation may be applied with either left or right hands or using an extension probe, grounding pads, or ear clips. Other standard accessories include a 9-volt battery, carrying case, and instruction manual. FDA UDI

Identifiers

Primary DI / UDI-DI
00628176737003 FDA UDI
510(k) Number
K023726 FDA UDI
K133789 FDA UDI
FDA Product Code
GZJ FDA UDI
NUH FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

Dolphin Neurostim by Center For Pain and Stress Research Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Cleared under the same submission

K023726 also covers:

K133789 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Center For Pain and Stress Research Ltd

Sources (1)

  • FDA UDI a10156fd-ed7b-4272-8092-cc1bb53a555b 35 fields · synced Jun 1, 2026