FDA.reportPublic FDA data

PUREHEAL Overlapped Compression Therapy

Primary DI
06976331789102
Brand
PUREHEAL Overlapped Compression Therapy
Company
Joicom Corporation
Model
PH-F01
Published
2023-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IRPMassager, Powered Inflatable Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221862000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221862000YY-A02-B Overlapped Compression TherapyHuizhou Xinyi Technology Co., Ltd.2022-12-08IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16976331789109PackageGS18In Commercial Distribution
06976331789102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697633178910916976331789109
06976331789102069763317891026976331789102

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid thermal/compression therapy system wrapA non-sterile component of a circulating-fluid thermal/compression therapy system intended to facilitate, through thermal therapy (heating and/or cooling) and compression, the treatment of a variety of adverse conditions resulting from a musculoskeletal injury/orthopaedic surgery (e.g., pain, swelling, inflammation). It is intended to be fastened around a single or multiple anatomies and consists of: a heat exchanger, which enables heated and/or cooled fluid from the system control unit to be circulated; and an external sleeve, which enables intermittent compression via inflation. It is intended for use in both professional and home settings. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033774836
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810140062833RENPHOPUS-R-WTR01-BK2026-07-24
00810140063113RENPHOPUS-R-WMV01-BU2026-07-24
00810140063120RENPHOPUS-R-WTR10-BK2026-07-24
00810140063106Renpho Massage GunR-WMG042026-07-21
00810140063052RenphoR-HAP092026-06-23
00810140063069RenphoR-HAP102026-06-23
00810140063076RenphoR-G0062026-06-23
00810140063083RenphoR-L0012026-06-23
00810140063090RenphoSKB-24182026-06-23
00810140063045RENPHO Eye MassagerR-WME062026-05-26
00810140063014RENPHOPUS-R-WMV01-2-BK2026-05-08
00810140063021RENPHOPUS-R-WMG18-BK2026-05-08
00810140063038RENPHOPUS-R-WMG09-GY2026-05-08
00810140063007RENPHOPUS-R-MSC05-BK2026-04-20
00810140062994RENPHOPUS-R-MSC06-BK2026-04-08
00810140062895RENPHOPUS-R-WMF01-WH2026-01-04
00810140062901RENPHOPUS-R-A018-BU-B12026-01-04
10810140062892RENPHOPUS-R-WMF01-WH2026-01-04
10810140062908RENPHOPUS-R-A018-BU-B12026-01-04
00810140062864RENPHOPUS-R-WMF08-BU2025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812120004895Game Ready* SystemAvanos Medical, Inc.IRP2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.IRP2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.IRP2026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.IRP2026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.IRP2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.IRP2026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.IRP2026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.IRP2026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005250Game Ready* Straight Knee SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005267Game Ready* Articulated Knee SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005274Game Ready* Straight Elbow SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005281Game Ready* Ankle Sleeve, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005298Game Ready* Ankle Sleeve, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005304Game Ready* Shoulder Sleeve, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005311Game Ready* Shoulder Sleeve, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005328Game Ready* Shoulder Sleeve, Large, RightAvanos Medical, Inc.IRP2026-07-31
00812120005335Game Ready* Shoulder Sleeve, Large, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005342Game Ready* Back SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005359Game Ready* C-T Spine Sleeve, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005366Game Ready* Hip/Groin Sleeve, RightAvanos Medical, Inc.IRP2026-07-31
00812120005373Game Ready* Hip/Groin Sleeve, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005380Game Ready* Hand/Wrist SleeveAvanos Medical, Inc.IRP2026-07-31