FDA.reportPublic FDA data

Large Massage Ball

Primary DI
00854103007271
Brand
Large Massage Ball
Company
LITECURE LLC
Model
PRD-000229-000-L
Device description
BDA Attachment head Large Ball
Published
2022-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854103007271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854103007271008541030072718541030072710854103007271

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal/physical therapy laser beam guide tip, transcutaneousA device intended to be connected to a hand-held laser beam guide to deliver visible red/infrared laser light energy to the skin-surface for localized treatment of underlying musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation. It incorporates fibreoptic/light transmitting materials and is intended to connect to the distal end of the applicator, and may include features to allow for manual massage as an adjunct to laser energy therapy (e.g., integrated massage ball). It is intended to be operated by a healthcare professional exclusively in a clinical setting. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
858768943
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854103007004LightForce PROLTC-9002017-02-07
00854103007011LightForce FXLTC-15002017-02-07
00854103007028LightForce EXLTS-15002017-02-07
00854103007035LightForce EXPLTS-1500P2017-02-07
00854103007295LightForce XLTC-1001-L-B62022-11-03
00854103007097LightForce FXiLTC-1510-L-B62020-10-30
00854103007103LightForce XPiLTS-2500-L-S82020-10-30
00854103007073LightForce XLiLTS-4000-L2019-12-13
00854103007066SoLa Therapy LaserLTC-1510-SOLA2019-06-20
00854103007042LightForce FXiLTC-15002017-07-24
00854103007059LightForce EXPiLTS-25002017-07-24
00854103007332Large Massage BallPRD-000229-010-002022-11-22
00854103007349Flat WindowPRD-000233-0002022-11-22
00854103007318XL ConePRD-000644-0002022-08-23
00854103007325XL Rolling PinPRD-000721-0002022-08-23
00854103007110Empower Delivery SystemPRD-000424-010-01-L2022-06-30
00854103007134Empower IQ Delivery SystemPRD-000758-010-00-L2022-06-30
00854103007165Empower Delivery SystemPRD-000477-000-01-L2022-06-30
00854103007172Empower Delivery SystemPRD-000477-000-02-L2022-06-30
00854103007189Empower Delivery SystemPRD-000477-000-03-L2022-06-30

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