Duns Number:319241873
Device Description: Electronically powered device with a vibrating mode to treat the neck muscles. Optionally Electronically powered device with a vibrating mode to treat the neck muscles. Optionally with heating function by red light. It is typically used for physiotherapie e.g reduce muscular tensions for domestic use.
Catalog Number
99538
Brand Name
Medisana
Version/Model Number
NM 10L
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
ISA
Product Code Name
Massager, Therapeutic, Electric
Public Device Record Key
247462bd-7c97-43c3-b202-c47fd0ad645b
Public Version Date
July 15, 2021
Public Version Number
3
DI Record Publish Date
September 06, 2019
Package DI Number
04015588998171
Quantity per Package
4
Contains DI Package
04015588995385
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
cardbox
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |