FDA.reportPublic FDA data

3H Smart Massage Bed

Primary DI
08809524497691
Brand
3H Smart Massage Bed
Company
3H, Co., Ltd
Model
SA-820R US
Published
2026-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
08809524497691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809524497691088095244976918809524497691

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.

Regulatory Flags#

DUNS number
690390383
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
088095244976843H Smart Massage Bed3H-820WD US2026-07-29
088095244977073H Smart Massage BedSD-820SJ US2026-07-29
088095244977143H Smart Massage Bed3H-920C US2026-07-29
088095244977213H Smart Massage Bed3H-920CV US2026-07-29
088095244977383H Smart Massage Bed3H-1300N US2026-07-29
088095244977453H Smart Massage Bed3H-1300WD US2026-07-29
088095244977523H Smart Massage Bed3H-1530K US2026-07-29
088095244977693H Heating Belt3h-1370 US2026-07-29
088095244977763H Abdomen Fomentation Device3H-780 US2026-07-29
088095244977833H Abdomen Fomentation Device3H-2030 US2026-07-29
088095244976773H Smart Massage Bed3H-820 US2026-07-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088095244976843H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977073H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977143H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977213H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977383H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977453H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977523H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244976773H Smart Massage Bed3H, Co., LtdISA2026-07-28
00810140063106Renpho Massage GunJoicom CorporationISA2026-07-21
00810140063076RenphoJoicom CorporationISA2026-06-23
06972433811246JermeiShenzhen Jermei Medical Device Technology Co.,LtdISA2026-06-10
00850071298017Smart-RSTHyperion Medical Technologies, Inc.ISA2026-06-02
16973368290059MedisanaZhangzhou Easepal Medical Science And Technology Co., Ltd.ISA2026-04-30
07630039101855MASTERPULS®Storz Medical AGISA2026-04-15
00045915831424Human TouchHuman Touch, LLCISA2026-01-12
00045915831431Human TouchHuman Touch, LLCISA2026-01-12
00045915831448Human TouchHuman Touch, LLCISA2026-01-12
00045915831455Human TouchHuman Touch, LLCISA2026-01-12
00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
00197344153605MEDLINEMEDLINE INDUSTRIES, INC.ISA2025-10-17
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.ISA2025-07-15
00810140061355RENPHOJoicom CorporationISA2024-11-19
00810140061362RENPHOJoicom CorporationISA2024-11-19
00810140061379RENPHOJoicom CorporationISA2024-11-19
00074108453488CONAIRCONAIR CORPORATIONISA2024-10-07