Duns Number:530683813
Device Description: Pain Therapy 4-PadThis is intended for the relief of pain associated with sore or aching m Pain Therapy 4-PadThis is intended for the relief of pain associated with sore or aching muscles in the following anatomical locations: the lower back, shoulders, arms and legs due to strain from exercise or ADL’s (activities of daily living) principally regular household and work activities.
Catalog Number
-
Brand Name
DR-HO'S
Version/Model Number
P.T.S-II
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)
-
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
7d62c05b-3405-4604-af75-f4521381faca
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
March 01, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |