Duns Number:788403103
Device Description: The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibrator The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motorsorganized into zones. The vest may be run on battery or A/C power from a standard wall outlet.The AffloVest is intended for promoting airway clearance and improvement of bronchialdrainage by enhancing mobilization of bronchial secretions where external manipulation of thethorax is the physician’s choice of treatment.
Catalog Number
-
Brand Name
AffloVest
Version/Model Number
8300XL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 29, 2022
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122480
Product Code
BYI
Product Code Name
Percussor, Powered-Electric
Public Device Record Key
61a4f277-d7a3-414f-bbe4-a1f84233c863
Public Version Date
May 03, 2022
Public Version Number
4
DI Record Publish Date
November 24, 2015
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |