Duns Number:098639974
Device Description: The G5® GK-3® Classic is a quiet & powerful Massage Machine designed for rugged use in the The G5® GK-3® Classic 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. This special priced unit comes in our Classic Housing, as pictured.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
GK120B
Brand Name
G5®
Version/Model Number
GK120B
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
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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
1b4b82d6-3d18-4d23-8d89-336ff38e31bb
Public Version Date
October 08, 2020
Public Version Number
4
DI Record Publish Date
May 12, 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 |