Duns Number:530683813
Device Description: Air Wave CushionThis product is suitable for people who sit for a long time to relieve the Air Wave CushionThis product is suitable for people who sit for a long time to relieve the fatigue caused by sitting for a long time. It's compose by cushion, cushion sleeves.The product is mainly formed through blister molding, forming a number of air bags arranged, the pressure technology between the air bags can effectively balance the pressure, to ensure that each air bag receives the same pressure, through other flow to massage the hip, relieve the fatigue caused by sitting for a long time.
Catalog Number
-
Brand Name
DR-HO'S
Version/Model Number
AWC-1
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"
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For Single-Use
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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
IPM
Product Code Name
Cover, Limb
Public Device Record Key
cde067bd-8918-4e6a-82c2-b9e516a836b7
Public Version Date
March 09, 2020
Public Version Number
1
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 |