SPT

GUDID 00876840016231

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.

SUNPENTOWN INTERNATIONAL, INC.

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID00876840016231
NIH Device Record Key19eabbb2-cc55-4d27-9f1f-002224e541b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPT
Version Model NumberUC-031
Company DUNS848632097
Company NameSUNPENTOWN INTERNATIONAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100876840016231 [Primary]
GS110876840016238 [Package]
Package: Carton [12 Units]
In Commercial Distribution

FDA Product Code

NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-23
Device Publish Date2017-02-17

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