FDA.reportPublic FDA data

Shuhai Jingwei

Primary DI
06977444420005
Brand
Shuhai Jingwei
Company
Shuhai Jingwei (Shenzhen) Information Technology Co., Ltd.
Model
Version1.0
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977444420005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977444420005069774444200056977444420005

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Regulatory Flags#

DUNS number
713317199
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884400829658Hubble-24AMAZE Neuro, Inc.HCC2026-08-27
00884400833297Voyager-7AMAZE Neuro, Inc.HCC2026-08-27
08800250281332QuadtheraECO DM LAB Co., Ltd.ISA2026-08-21
00817915020296Etekcity Smart Fitness ScaleVesync (US) CorporationISA2026-08-14
088095244976843H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244976913H 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
00860015825803JOGO-GxJogohealth, Inc.HCC2026-07-27
00810140063106Renpho Massage GunJoicom CorporationISA2026-07-21
07540191000678NeuroInfinitiThought Technology Ltd.HCC2026-07-06
00810140063076RenphoJoicom CorporationISA2026-06-23
06972433811246JermeiShenzhen Jermei Medical Device Technology Co.,LtdISA2026-06-10
G345SL2000CIONICCionic, Inc.HCC2026-06-04
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
08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
08719481550110NeXus 10 MK3Mind Media Europe B.V.HCC2025-09-10
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.ISA2025-07-15
50885380198791KangarooCardinal Health 200, LLCHCC2025-03-12
09361725000142BON CHARGEBLUBLOX PTY LTDISA2024-12-23
10853818007504USB C AdapterPRECISION BIOMETRICS INCHCC2024-09-03
08592566001208Disposable blunted needlesDEYMED Diagnostic s.r.o.HCC2023-10-26