Duns Number:098639974
Device Description: The G5 GBM Professional Portable Massager is our most powerful hand-held device. It incorp The G5 GBM Professional Portable Massager is our most powerful hand-held device. It incorporates the powerful massage action of our stand-mounted G5 Massage Machines into a small, compact, hand-held unit - a massager small enough on the outside to fit in a gym bag, but big enough on the inside to consistently deliver a powerful, deep-penetrating massage action. The G5 GBM is ideal for the athletic trainers or athletes on the go! Comes with our Professional Portable Applicator Package. G5 Travel Bag sold seperately. The G5 GBM massager is beneficial to anyone who competes, works out, or is involved in strenuous work. Before an activity, use it to enhance flexibility, increase range-of-motion, and reduce the risk of muscle spasms, strains or contusions. After exertion, rely on the G5 GBM to accelerate the healing process, to reduce pain and swelling by flushing out lactic acid buildup in the muscles, and to relieve muscle pain caused by work and stress.Unit Advantages: Portable device with the same quality and durability as our larger models Ergonomical grip points for convenient one or two handed operation. Variable speed control: 15 - 55 cycles per second
Catalog Number
GBM 24 B
Brand Name
G5®
Version/Model Number
GBM 24 B
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
3eab7e02-15b8-4427-9c0c-58055e579de1
Public Version Date
September 29, 2020
Public Version Number
4
DI Record Publish Date
March 01, 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 |