Duns Number:098639974
Device Description: The G5 TherAssist is our latest advancement in massage/percussion technology for use in bo The G5 TherAssist is our latest advancement in massage/percussion technology for use in both physical and respiratory therapy applications. The TherAssist is ideal for use in physical therapy, respiratory therapy, and sports medicine applications. This unit features digital solid-state electronic controls. Includes a timer. An expanded cycle per second range (10 - 60 CPS) more closely replicates manual procedures. Ideal for stress reduction, myofascial release, sports rehabilitation, deep muscle therapy, trigger point reduction, treatment of muscle spasm, pain relief by mobilizing lactic acid, and postural drainage.
Catalog Number
TS240W
Brand Name
G5®
Version/Model Number
TS240W
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
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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
67cab76c-8a9c-4cb5-997b-66e82fe9c20b
Public Version Date
September 29, 2020
Public Version Number
5
DI Record Publish Date
April 26, 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 |