Duns Number:098639974
Device Description: The G5 Vibracare Percussor is our durable, hand-held percussor used in respiratory therapy The G5 Vibracare Percussor is our durable, hand-held percussor used in respiratory therapy applications. Totally self-contained, and weighing less than three pounds, it provides optimal freedom of movement and portability with a ten foot hospital grade power cord. This model may be used with a variety of applicators and has a continuously-variable speed range of 20 - 50 cycles per second. This combination of applicators and speeds provides for a highly-versatile treatment range. It is the only hand-held percussor/massager to be granted C.S.A's highest medical operational rating. Comes with applicators 250, 251, 253 and 234. No other applicators will fit this unit. A pediatric version is also available.
Catalog Number
VC 24 B
Brand Name
G5®
Version/Model Number
VC 24B
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
ISA
Product Code Name
Massager, Therapeutic, Electric
Public Device Record Key
df13e666-a4df-4784-bb77-cc46e9fb9c6e
Public Version Date
September 22, 2020
Public Version Number
4
DI Record Publish Date
February 09, 2017
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 355 |