Duns Number:848632097
Device Description: Delivers electric impulses to tired and sore muscles. The muscles respond to the impulses 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.
Catalog Number
-
Brand Name
SPT
Version/Model Number
UC-031
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
19eabbb2-cc55-4d27-9f1f-002224e541b7
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
February 17, 2017
Package DI Number
10876840016238
Quantity per Package
12
Contains DI Package
00876840016231
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton