SPT

Basic Information

• Brand Name: SPT
• Primary DI: 00876840016231
• Version / Model: UC-031
• Company Name: SUNPENTOWN INTERNATIONAL, INC.
• Labeler DUNS: 848632097
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-17
• Public Version: 3
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: 19eabbb2-cc55-4d27-9f1f-002224e541b7

Device Description

Delivers electric impulses to tired and sore muscles. The muscles respond to the impulses by contracting and relaxing rhythmically, which sends soothing massage sensations to relieve muscle tension and soreness. Six massage modes with 10 intensity levels each provide various combinations of massage sensaations. The body tends to get accustomed to one particular sensation and will eventually stop responding to it, the different sensations available on this unit ensures that the body does not become desensitized.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
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
Primary	00876840016231	GS1
Package	10876840016238	GS1	Carton	12	In Commercial Distribution