Dolphin Neurostim

Basic Information

• Brand Name: Dolphin Neurostim
• Primary DI: 00628176737003
• Version / Model: Classic
• Company Name: Center For Pain and Stress Research Ltd
• Labeler DUNS: 251050084
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-16
• Public Version: 1
• Public Version Date: 2021-09-24
• Public Version Status: New
• Public Device Record Key: a10156fd-ed7b-4272-8092-cc1bb53a555b

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	882.5890	2
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	882.5890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35372	Analgesic transcutaneous electrical nerve stimulation system	An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10628176737000	GS1	Carrying Case	1	In Commercial Distribution
Primary	00628176737003	GS1
Package	20628176737007	GS1	Carrying Case	2	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K023726	000
K133789	000