Duns Number:098639974
Device Description: The G5® ALC Over-The-Shoulder Massage Machine produces a non-invasive therapy treatment fo The G5® ALC Over-The-Shoulder Massage Machine produces a non-invasive therapy treatment for skin, scalp, tissue, muscles, lymph nodes and the circulatory system. A wide array of applicators combine with the ALC unit to provide aesthetic services such as cellulite reduction, exfoliation, lymphatic drainage, body contouring, skin toning and muscle relaxation. Comes complete with caster stand, accessory tray, and applicators. Unit Advantages: • Versatility: Pole, Table Top • Portability: In-mold handle and smooth casters to easily move from room to room • CPS Indicator on Control Panel • Extra tall stand so cable can hang over the operator’s shoulder for ease of use
Catalog Number
ALC 240 G5
Brand Name
G5®
Version/Model Number
ALC 240 G5
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
22a2de93-f1b9-4eec-8984-a69357f83452
Public Version Date
September 28, 2020
Public Version Number
4
DI Record Publish Date
May 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 |