Duns Number:098639974
Device Description: The G5 Pro-Power massager is beneficial to anyone who competes, works out, or is involved The G5 Pro-Power 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 Pro-Power Massager 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. Excellent for the relief of, repair of, and resistance to repetitive motion disorders. (Carpal Tunnel Syndrome, tendonitis, tenosynovitis, etc.) The head of the G5 Pro-Power accepts all genuine G5 Brand massage applicators.Unit Advantages: Portable: only 12" long Lightweight: weighs only 3 lbs. Hand-held device with a soft rubber grip Variable speed control: 20 - 50 cycles per second
Catalog Number
PP 24 B
Brand Name
G5®
Version/Model Number
PP 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
c51f4950-6f22-41d9-9b91-e75283eb1c57
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 |