FDA.reportPublic FDA data

PainShield Plus 3.0 Driver

Primary DI
07290103422035
Brand
PainShield Plus 3.0 Driver
Company
NANOVIBRONIX INC.
Model
3.0
Catalog number
10-800-0006
Device description
PainShield MD Plus is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions including pain and soft tissue injuries. The low intensity and low-frequency ultrasound energy is effective within a diameter of 20 cm and depth of approximately 3 cm.
Published
2023-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
07290103422035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290103422035072901034220357290103422035

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
914-233-3004info@nanovibronix.com

Regulatory Flags#

DUNS number
080326793
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290103422028PainShield 3.0 Driver 3.010-800-00022023-07-16
07290103421311PainShield MD Plus3.010-400-00012022-05-16
07290103421236PainShield MD Kit3.010-100-00012020-12-22
07290103421267PainShield MD Plus Supplies Kit3.010-400-00022022-05-16
07290103421168PainShield MD Supplies Kit3.0 10-100-00132020-12-22
07290103420277UroShield 3.0 Driver3.010-800-00032023-07-25
07290103422011PainShield Patch3.010-500-00072023-07-24
07290103421144PainShield 3.0 Actuator3.010-600-00022023-07-16
07290103421328PainShield Plus Actuator 3.010-600-00072023-07-16
07290103421014PainShieldPS-302019-07-28
07290103420123UroShield Actuaor 10 pack3.0 Actuator10-200-00022021-05-04
07290103420116UroShield Actuator3.0 actuator10-600-00032020-12-22
07290103420260UroShield Kit3.010-200-00042020-12-22
07290103421229Reusable PatchPRP-202019-07-28
07290103421250Reusable Facial PatchPRP-402019-07-28

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
00857599005202sam X1ZETROZ SYSTEMS, LLCPFW2022-09-29
00810113682396ManaSport+Manamed, Inc.PFW2022-06-20