FDA.reportPublic FDA data

PainShield

Primary DI
07290103421014
Brand
PainShield
Company
NANOVIBRONIX INC.
Model
PS-30
Device description
PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area. The user may feel minor warmth at the treatment patch site during the treatment period. PainShield MD should be used under the prescription of a physician or physical therapist. PainShield MD is comprised of two elements: a treatment patch that contains the transducer, which delivers ultrasound waves and a portable battery-operated driver.
Published
2019-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
07290103421014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290103421014072901034210147290103421014

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy ultrasound systemAn assembly of devices designed to produce and deliver ultrasonic waves that penetrate tissues and produce both thermal and nonthermal (e.g., mechanical and cavitation) effects to treat pain (e.g., muscle, tendon, joint) and as an aid in the healing of soft-tissue injuries (e.g., ulcerations, bursitis). It typically consists of a radio-frequency (RF) generator (frequencies from one to three megahertz are typical), a cable that transmits the RF energy to the applicator, and an applicator including a piezoelectric transducer that applies the ultrasonic energy to the patient's tissues through the skin.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity40 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius27 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
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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
07290103422035PainShield Plus 3.0 Driver 3.010-800-00062023-07-16
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
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
07290103422035PainShield Plus 3.0 Driver NANOVIBRONIX INC.PFW2023-07-16
00857599005202sam X1ZETROZ SYSTEMS, LLCPFW2022-09-29