FDA.reportPublic FDA data

HILL Laboratories Company

Primary DI
08908008085307
Brand
HILL Laboratories Company
Company
SYRMA JOHARI MEDTECH LIMITED
Model
HF54
Published
2019-01-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PFWStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFWStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep HeatPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908008085307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908008085307089080080853078908008085307

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy ultrasound/neuromuscular stimulation systemAn assembly of devices that includes a neuromuscular electrical stimulator as an integral part of a therapeutic ultrasound system intended for the simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and to help reduce muscle spasms and pain; it may in addition be capable of delivering either energy alone. The system is designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
675938472
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08908008085000Johari Digital Healthcare LimitedWS4U-Combo Device2016-09-19
08908008085017Johari Digital Healthcare LimitedWS2U-Combo Device2016-09-19
08908008085024Johari Digital Healthcare LimitedWSU2016-09-19
08908008085031Johari Digital Healthcare LimitedJUS22016-09-19
08908008085499Syrma Johari MedTech LimitedMyolift QT+2025-07-08
08908008085055Johari Digital Healthcare LimitedX Trainer2016-09-19
08908008085130Johari Digital Healthcare LimitedNMS4982016-09-19
08908008085192Mettler Electronics Corp.SYSSTIM 208/208A2016-09-19
08908008085253Johari Digital Healthcare LimitedNeubie2017-09-11
08908008085260Johari Digital Healthcare LimitedNeuro-M Trainer Model A2017-09-11
08908008085475Johari Digital Healthcare Ltd.MyoBody XT2025-02-04
08908008085468Johari Digital Healthcare Ltd.Zeta Cranial Navigation System2024-01-25
08908008085451Johari Digital Healthcare Ltd.truFlex2024-01-24
08908008085444Johari Digital Healthcare Ltd.MYOLIFT 600+2023-12-04
08908008085437Johari Digital Healthcare Ltd.Myolift TW2023-03-17
08908008085413Johari Digital Healthcare Ltd.Sonicaor Plus 9212021-06-04
08908008085420Johari Digital Healthcare Ltd.Sonicaor Plus 9412021-06-04
08908008085406Johari Digital Healthcare Ltd.MINDGEAR2021-03-12
08908008085376Johari Digital Healthcare Ltd.Myolift 6002020-10-30
08908008085383Johari Digital Healthcare Ltd.STIM TENS2020-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857599005271sam 2.0 OA multi-hour continuous ultrasound device for home useZETROZ SYSTEMS, LLCPFW2026-04-07
00850033615227Echo Ultrasound Device (PRC) THERMOTEK, INC.PFW2026-02-23
00850033615258Echo Ultrasound Device (PRC)THERMOTEK, INC.PFW2026-02-23
00850033615289Echo Ultrasound Device (USA)THERMOTEK, INC.PFW2026-02-23
00850033615340Echo Ultrasound Device (USA)THERMOTEK, INC.PFW2026-02-23
00850033615371Echo BOX, DRESSING & GEL POD PACK, USND, PRCTHERMOTEK, INC.PFW2026-02-23
00850033615388Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXESTHERMOTEK, INC.PFW2026-02-23
00850033615425Echo Ultra Sound Gel Pods, CartonTHERMOTEK, INC.PFW2026-02-23
00850033615487Echo Ultra Sound Gel Pod, SingleTHERMOTEK, INC.PFW2026-02-23
00850033615500Echo APPLICATOR, SINGLE, USNDTHERMOTEK, INC.PFW2026-02-23
00850033615517Echo POWER SUPPLY, CORD, SINGLE, USNDTHERMOTEK, INC.PFW2026-02-23
00850033615531Echo BELT CLIP, DEVICE PRTCTR, SNGL,USNDTHERMOTEK, INC.PFW2026-02-23
00850033615555Echo ARM STRAP, DEVICE PRTCTR, SNG, USNDTHERMOTEK, INC.PFW2026-02-23
00850033615562Echo GEL, TUBE, SINGLE, USNDTHERMOTEK, INC.PFW2026-02-23
00850033615586echoRx, MANUAL, USER, SINGLE, USNDTHERMOTEK, INC.PFW2026-02-23
00850033615593echoRx, GUIDE,QUICK START,SNGL,USNDTHERMOTEK, INC.PFW2026-02-23
00850033615623Echo CTN, DRESSINGS, USND, USA, QTY 4 BOXESTHERMOTEK, INC.PFW2026-02-23
00850033615630Echo BOX, DRESSING & GEL POD PACK, USND, USATHERMOTEK, INC.PFW2026-02-23
00810113682778ManaMed Transducer Holder PatchManamed, Inc.PFW2025-09-11
00810113682754ManaMed Transducer Fixation StrapManamed, Inc.PFW2025-09-11
00810113682761ManaMed Transducer Fixation StrapManamed, Inc.PFW2025-09-11
00857599005257sam(R) Advanced Gel Capture PatchZETROZ SYSTEMS, LLCPFW2024-10-10
00857599005172sam(R) Advanced Gel Capture PatchZETROZ SYSTEMS, LLCPFW2024-10-10
00857599005165sam(R) Advanced Gel Capture PatchZETROZ SYSTEMS, LLCPFW2024-10-10
07290103422011PainShield PatchNANOVIBRONIX INC.PFW2023-07-24
07290103421144PainShield 3.0 ActuatorNANOVIBRONIX INC.PFW2023-07-16
07290103421328PainShield Plus Actuator NANOVIBRONIX INC.PFW2023-07-16
07290103422028PainShield 3.0 Driver NANOVIBRONIX INC.PFW2023-07-16
07290103422035PainShield Plus 3.0 Driver NANOVIBRONIX INC.PFW2023-07-16
00857599005202sam X1ZETROZ SYSTEMS, LLCPFW2022-09-29