FDA.reportPublic FDA data

Healthpal

Primary DI
06974000130026
Brand
Healthpal
Company
Xiamen Healthpal Electronic Co., Ltd.
Model
FE-7513
Published
2025-01-02
Public version status
New
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
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
06974000130026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974000130026069740001300266974000130026

GMDN Terms#

Term, Definition table
TermDefinition
Body infrared reflective phototherapy skin patchA skin patch intended to reflect naturally emitted infrared energy back into the body, with a reduced range of wavelength (phototherapeutic stimulation of the skin), to assist one or more of the following therapeutic outcomes: wound healing, pain relief, improved energy, improved sleep, reduced cravings, and general wellbeing. It can be applied as a single, double or multiple patch(es). This is a single-use 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
06974000130002HealthpalFE-01612025-01-04
06974000130019HealthpalFE-7204B2025-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809040526691AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526707AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526714AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526721AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809802644885LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
08809802644892LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
08809802644908LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
08809802644915LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
08809040526776Air Relax Classic Model AR-1.0 ControlUnit OnlyMaxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526783Air Relax Classic Model AR-1.0 Leg Recovery System-Size 2Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526790Air Relax Classic Model AR-1.0 Leg Recovery System-Size 3Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526806Air Relax Classic Model AR-1.0 Leg Recovery System-Size 4Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.IRP2025-07-15
08809494000686CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
08809494000983CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
08809802644526LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644533LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644540LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644557LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644564LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644571LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644588LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644595LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644601LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644618LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644625LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644632LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644649LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644656LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644663LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20