Duns Number:529449417
Device Description: Pain Therapy Device is a new generation of effective health-care device developed based on Pain Therapy Device is a new generation of effective health-care device developed based on physics, bionics, electrobiology and modern microelectronics as well as a lot of clinical practice. The device is used for temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, neck, upper extremities(arm), and lower extremities(leg) due to strain from exercise or normal household work activities.
Catalog Number
-
Brand Name
Counter
Version/Model Number
PTS-IV
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
K161537,K161537,K161537
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
9ec935fb-7dd5-4a12-a428-32149d5ea31e
Public Version Date
March 17, 2021
Public Version Number
2
DI Record Publish Date
March 08, 2021
Package DI Number
26970368250011
Quantity per Package
12
Contains DI Package
06970368250017
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-