{"publicDeviceRecordKey":"e7155837-bbf2-4e0b-8c61-a261c4965d17","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-07-24T00:00:00.000Z","devicePublishDate":"2023-07-16T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"07290103421144","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PainShield  3.0 Actuator","versionModelNumber":"3.0","catalogNumber":"10-600-0002","dunsNumber":"080326793","companyName":"NANOVIBRONIX INC.","deviceCount":1,"deviceDescription":"PainShield actuator is part of the PainShield MD System.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Unsafe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"914-233-3004","phoneExtension":null,"email":"info@nanovibronix.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"65731","gmdnPTName":"Physical therapy ultrasound system applicator, adhesive","gmdnPTDefinition":"A component of a physical therapy ultrasound system that includes a transducer designed to convert electric voltages into ultrasound energy [e.g., frequencies greater than 20 kilohertz (kHz)] and directs this energy into body tissues; it is held in place on the skin by an adhesive patch typically for several hours. The localized thermal and nonthermal effects generated by the ultrasonic energy is associated with increased blood flow in the treated area and is intended to accelerate tissue repair and/or reduce pain. Disposable adhesive patches are included with the device. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"PFW","productCodeName":"Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"80"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"10"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"40"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"5"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}