FDA.reportPublic FDA data

Healthpal

Primary DI
06974000130019
Brand
Healthpal
Company
Xiamen Healthpal Electronic Co., Ltd.
Model
FE-7204B
Published
2025-01-02
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
IRPMassager, Powered Inflatable Tube

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211850000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211850000Air Compression Leg Massager (model: FE-7204B)Xiamen Healthpal Electronic Co.,Ltd2022-03-03IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974000130019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974000130019069740001300196974000130019

GMDN Terms#

Term, Definition table
TermDefinition
Leg friction/impact protectorA device designed to be worn over the leg to provide a cushion to protect the limb and its skin from friction against surfaces and knocks against objects. It is typically made of fabric or soft padded materials and is held in place with bands or straps around the leg, or has a tubular sock design; it is not dedicated to the ankle/foot. It is typically used by persons who have thinning skin or skin sores on their legs, are bedridden, or prone to lack of control with their legs causing injury. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
553874367
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974000130033HealthpalFE-71082026-08-26
06974000130002HealthpalFE-01612025-01-04
06974000130026HealthpalFE-75132025-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050289252HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289269HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289276HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289283HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289290HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289306HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
06959557201382Air Compression Therapy DeviceSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-10-15
03858894530502ZT Cube - ZC3ZAMAR MEDICAL d.o.o.IRP2026-10-12
03858894530618ZT CLINICZAMAR MEDICAL d.o.o.IRP2026-10-12
06976331781397AnacondafightwearHuizhou XINYI Technology Co., LTDIRP2026-10-12
06959557201375Air Compression Therapy DeviceSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-10-10
06959557200286Powered Inflatable Tube MassagerSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-09-30
06974000130033HealthpalXiamen Healthpal Electronic Co., Ltd.IRP2026-08-26
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