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#

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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
10810140062861RENPHOPUS-R-WMF08-BU2025-12-16
00810140062857RENPHOR-WMG242025-12-03
10810140062854RENPHOR-WMG242025-12-03
00810140062840RENPHOR-MSB042025-11-25
10810140062847RENPHOR-MSB042025-11-25
00810140062123RENPHOR-WMG102024-10-16
00810140062826RENPHOPUS-R-WMF09-BK2025-11-05
00810140062819RENPHOES-CS20M2025-10-24
00810140062802RENPHO Massage GunR-WMG152025-10-22

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