FDA.reportPublic FDA data

Top Shelf Orthopedics

Primary DI
00850016589477
Brand
Top Shelf Orthopedics
Company
Top Shelf Manufacturing, LLC
Model
508211
Catalog number
508211
Device description
Multiuse Pad, Sierra Cold Therapy System
Published
2024-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, Hot Or Cold, Water Circulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850016589477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016589477008500165894778500165894770850016589477

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid localized thermal therapy system pack, single-useA device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-592-0488info@topshelfortho.com

Regulatory Flags#

DUNS number
114134625
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850016589187Top Shelf Orthopedics5105235105232023-05-04
00850016589194Top Shelf Orthopedics5105245105242023-05-04
00850016589200Top Shelf Orthopedics5105275105272023-05-04
00850016589217Top Shelf Orthopedics5105255105252023-05-04
00850016589224Top Shelf Orthopedics5105265105262023-05-04
00850016589408Top Shelf Orthopedics5082005082002024-03-18
00850016589415Top Shelf Orthopedics5082015082012024-03-18
00850016589422Top Shelf Orthopedics5082025082022024-03-18
00850016589460Top Shelf Orthopedics5082105082102024-03-18
00850016589484Top Shelf Orthopedics5082125082122024-03-18
00850016589002Top Shelf Orthopedics5300015300012020-12-18
00850016589019Top Shelf Orthopedics5300025300022020-12-18
00850016589026Top Shelf Orthopedics5300035300032020-12-18
00850016589033Top Shelf Orthopedics5300155300152020-12-18
00850016589040Top Shelf Orthopedics5300165300162020-12-18
10850016589009Top Shelf Orthopedics5300015300012020-12-18
10850016589016Top Shelf Orthopedics5300025300022020-12-18
10850016589023Top Shelf Orthopedics5300035300032020-12-18
10850016589030Top Shelf Orthopedics5300155300152020-12-18
10850016589047Top Shelf Orthopedics5300165300162020-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06973641880680Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880765Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880772Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880789Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880796Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880802Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880819Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880826Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-21
06973641880871CryoRxChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-07-19
00197344214740MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214757MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214733MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-08
06973641887146CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
06973641888518CryoRxChengdu Cryo-push Medical Technology Co.,Ltd.ILO2025-09-16
00311917069159WalgreensWALGREEN CO.ILO2025-08-22
00810113577517ViveVIVE HEALTH LLCILO2024-08-20
00810041987617ViveVIVE HEALTH LLCILO2024-07-17
10850007350090Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350106Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350120Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350073Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350110T/PadC2DX, INC.ILO2024-01-09
00810041981523ViveVIVE HEALTH LLCILO2023-08-07
08809802644038CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644045CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
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