Duns Number:544356011
Device Description: THERA-P FULL BODY MASSAGER
Catalog Number
-
Brand Name
Homedics
Version/Model Number
HHP-225HJ-THP
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
ISA
Product Code Name
Massager, Therapeutic, Electric
Public Device Record Key
5b54185d-8d5a-4d53-bb6c-a006a677c559
Public Version Date
August 20, 2020
Public Version Number
2
DI Record Publish Date
June 01, 2020
Package DI Number
10031262066647
Quantity per Package
2
Contains DI Package
00031262066640
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 61 |