FDA.reportPublic FDA data

Rolyan

Primary DI
00885914038659
Brand
Rolyan
Company
Performance Health Supply, LLC
Model
081296003
Device description
Rolyan Scar Pump
Published
2024-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LYGMassager, Therapeutic, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYGMassager, Therapeutic, ManualPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885914038659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885914038659008859140386598859140386590885914038659

GMDN Terms#

Term, Definition table
TermDefinition
External manual massager, clinicalA manual (non-powered) device designed to apply external massage to a patient, by the patient, staff, or a therapist in a hospital, institution, or therapeutic treatment situation. It is intended to stimulate/massage body muscles to provide a therapeutic effect. It is typically designed to be held in the hands and is available in a variety of configurations and materials, e.g., plastic, wood, ceramics. It is available in a variety of sizes and shapes and may be a one-piece device or have interchangeable massaging components (e.g., roller heads or pads), and have a variety of massage surfaces (e.g., points, ribs, smooth). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966806150
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885914040461Rolyan0813016392026-03-20
00885914040478Rolyan081301647N/A2026-03-20
00885914040485Rolyan081301654N/A2026-03-20
00885914004050METRON3030013030012016-09-16
00885914022023METRON9220999220992016-09-16
10885914075927METRON5687825687822017-01-31
10885914077440Performa0817107550817107552017-10-12
00885914077436Performa0817107480817107482017-10-13
00885914107898Sammons Preston70338453821302026-01-23
00885914107966Sammons Preston70338523821372026-01-23
00885914107973Sammons Preston70338533821382026-01-23
00885914107980Sammons Preston70338543821392026-01-23
00885914107997Sammons Preston70338553821402026-01-23
00885914108000Sammons Preston70338563821412026-01-23
00885914108017Sammons Preston70338573821422026-01-23
00885914108024Sammons Preston70338583821432026-01-23
00885914108031Sammons Preston70338593821442026-01-23
00885914108048Sammons Preston70338603821452026-01-23
00885914108055Sammons Preston70338613821462026-01-23
00885914108062Sammons Preston 70338623821472026-01-23

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