Duns Number:098639974
Device Description: The G5 ME 610 24 V is our latest advancement in massage/percussion technology for use in b The G5 ME 610 24 V is our latest advancement in massage/percussion technology for use in both physical and respiratory therapy applications. The ME 610 24V 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.Unit Advantages: Easy to use dial controls with visual displays of CPS, Time and Pulsation Range Speed feedback logic maintains CPS regardless of load. Versatility: Pole, Table Top and Wall Mountable Motor runs cooler with digital control (vs. analog control), requiring less amp draw and increasing motor life.
Catalog Number
ME 610 24 V
Brand Name
G5®
Version/Model Number
ME 610 24 V
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
aa202410-3500-401b-8097-0007ec95d39a
Public Version Date
October 08, 2020
Public Version Number
4
DI Record Publish Date
June 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 |