Duns Number:544356011
Device Description: SHIATSU NECK & BODY MASSAGER WITH SOOTHING HEAT
Catalog Number
-
Brand Name
Homedics
Version/Model Number
NMS-615HJ
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
0a3824be-1813-4a4a-a5c6-6ac07fc192a3
Public Version Date
July 12, 2021
Public Version Number
1
DI Record Publish Date
July 04, 2021
Package DI Number
10031262102598
Quantity per Package
3
Contains DI Package
00031262102591
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 |