Duns Number:098639974
Device Description: The G5 GK-3 is a quiet & powerful Massage Machine designed for rugged use in the office, c The G5 GK-3 is a quiet & powerful Massage Machine designed for rugged use in the office, clinic, school, gym, training room or home. Each GK-3 has a 47 3/4" long, light-weight, smooth drive cable attached to a durable applicator head, to provide greater versatility and ease of use. The GK-3 incorporates a dial-controlled, variable-speed output, with speeds from 20 - 60 cycles per second.Unit Advantages: Economical Stand Mount or Portable Configurations Basic Control Panel with CPS Indicator (Low, Medium, High) Comes complete with choice of applicator package
Catalog Number
GK 24 NB
Brand Name
G5®
Version/Model Number
GK 24 NB
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
-
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
e8c93d26-98a2-4811-8b47-4dcf8a9e9f81
Public Version Date
September 29, 2020
Public Version Number
4
DI Record Publish Date
April 25, 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 |