FDA.reportPublic FDA data

3H

Primary DI
08809524496809
Brand
3H
Company
3H, Co., Ltd
Model
3H-920 C-05
Published
2025-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809524496809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809524496809088095244968098809524496809

GMDN Terms#

Term, Definition table
TermDefinition
Massage table/couch, line-poweredA mains electricity (AC-powered) table designed for various kinds of complementary therapy (e.g., massage, acupuncture, aromatherapy, reflexology, kinesiology). It will typically consist of a framework with a flat table top surface which may have a head section that can be manually adjusted into a raised position. The height of the table is electrically adjusted. It may incorporate a face hole (the patient's face fits into this when lying prone), a headrest, and an armrest(s). This device is typically known as a massage/therapy table, couch or bed.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690390383
Device count
1
Premarket exempt
true
Combination product
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
088095244971583HSD-820 SJ-052025-06-12
088095244966873H3H-820 SJ-052025-05-30
088095244969393H3H-820 N-S-052025-05-30
088095244965333H3h-1370 S122025-05-30
088095244965953H3H-2030 S122025-05-30
088095244966703H3H-780 S122025-05-30
088095244966943HSD-820 SJ-S-052025-05-30
088095244967003H3H-820-052025-05-30
088095244967173H3H-820-S-052025-05-30
088095244967243H3H-820 SJ-052025-05-30
088095244967313H3H-820 SJ-S-052025-05-30
088095244967483H3H-850-052025-05-30
088095244967553H3H-850-S-052025-05-30
088095244967623H3H-850 WD-052025-05-30
088095244967793H3H-850 WD-S-052025-05-30
088095244967863H3H-920-052025-05-30
088095244967933H3H-920-S-052025-05-30
088095244968163H3H-920 C-S-052025-05-30
088095244968233H3H-920 WS-052025-05-30
088095244968303H3H-920 WS-S-052025-05-30

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