FDA.report

Cellu M6 Alliance Lab

Primary DI
B534CELLUM6LABMED1
Brand
Cellu M6 Alliance Lab
Company
L P G SYSTEMS
Model
Cellu M6 Alliance Lab Medical
Published
2023-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications

CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B534CELLUM6LABMED1PrimaryHIBCC0

GMDN Terms

TermDefinition
Large-area electric massagerAn electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may utilize vibrating belts or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment. This device is intended for use in healthcare facilities and is not applicable to home therapies.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
394430433
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B534CELLUM6ALLIANCEMED1Cellu M6 AllianceCellu M6 Alliance Medical2023-05-02
B534HUBER360MDEVO1HUBER360HUBER 360 EVOLUTION2023-05-02
B534WELLBOXDM1WELLBOXWELLBOX2023-05-02
B534HUBER360MDUS1HUBERHUBER2017-05-05

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