FDA.reportPublic FDA data

Wrist Massager

Primary DI
06974581810058
Brand
Wrist Massager
Company
ShenZhen Pentasmart Technology Co,.Ltd
Model
uWrist-6570A
Device description
Massager, Therapeutic, Electric
Published
2021-07-20
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
ISAMassager, Therapeutic, Electric

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974581810058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974581810058069745818100586974581810058

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held electric massagerAn electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
551250083
Device count
1
Premarket exempt
true
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
06974581810089Head MassageruIdea-6500B2021-08-30
06974581810096Head MassageruIdea-6501B2021-08-30
06974581810119Eye massageruLook-6510B2021-08-30
06974581810126Eye massageruLook-6511B2021-08-30
06974581810133Eye massageruLook -6512B2021-08-30
06974581810157Abdomen MassageruAngel-6532B2021-08-30
06974581810164Lumbar Traction DeviceuLumb-6533B2021-08-30
06974581810171Abdomen MassageruAngel-6530B2021-08-30
06974581810188Knee massageruLap-6550B2021-08-30
06974581810195Knee massageruLap-6553B2021-08-30
06974581810201Leg massageruLeg-6560B2021-08-30
06974581810218Wrist MassageruWrist-6570B2021-08-30
06974581810232Cupping DeviceuCute-2500B2021-08-30
06974581810256Cupping DeviceuCute-2503B2021-08-30
06974581810102Scalp MassageruScalp-65052021-08-26
06974581810225Massage GunuLax-6582A2021-08-26
06974581810010Eye massageruLook-6510A2021-07-20
06974581810027Knee massageruLap-6550A2021-07-20
06974581810034Leg massageruLeg-6560A2021-07-20
06974581810065Massage GunuLax-6580A2021-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800250281332QuadtheraECO DM LAB Co., Ltd.ISA2026-08-21
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088095244977073H Smart Massage Bed3H, Co., LtdISA2026-07-29
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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
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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
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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