FDA.reportPublic FDA data

swiftPro Battery Pack

Primary DI
05060652910138
Brand
swiftPro Battery Pack
Company
EMBLATION LIMITED
Model
SWF-BAT01
Catalog number
SWF-BAT01
Device description
The battery pack for the swiftPro Hand-held Microwave Generator
Published
2024-06-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NEYSystem, Ablation, Microwave And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEYSystem, Ablation, Microwave And AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240518000swiftPro™ SystemEmblation Limited2024-04-23NEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060652910138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060652910138050606529101385060652910138

GMDN Terms#

Term, Definition table
TermDefinition
Secondary batteryA rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The size, shape, and chemical composition of the battery should be specified according to the requirements of the appropriate IEC standard.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
211334261
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060652910053swiftPro SystemSWF-MIC01SWF-MIC012023-12-04
05060652910145swiftPro Charging DockSWF-CHG01SWF-CHG012024-06-26
05060652910152swiftPro Battery Power SystemSWF-BPS01SWF-BPS012024-06-26
05060652910060swiftPro Hand-Held Microwave GeneratorSWF-HAN01SWF-HAN012023-12-04
05060652910077swiftPro DC power adaptorSWF-DCA01SWF-DCA012023-12-04
05060652910084swiftPro CradleSWF-CRA01SWF-CRA012023-12-04
05060652910091swiftPro URT Applicator TipSWF-AT02SWF-AT022023-12-04
05060652910107swiftPro URT Applicator TipSWF-AT02-10SWF-AT02-102023-12-04
05060652910114swiftPro LRT Applicator TipSWF-AT03SWF-AT032023-12-04
05060652910121swiftPro LRT Applicator TipSWF-AT03-10SWF-AT03-102023-12-04
05060652910008Swift® Microwave GeneratorSWF-GE01SWF-GE012019-01-02
05060652910015Swift® Interconnect CableSWF-CA01SWF-CA012019-01-02
05060652910022Swift Applicator HandpieceSWF-HP01SWF-HP012019-01-02
05060652910039Swift® Applicator TipSWF-ATO1SWF-ATO12019-01-17
05060652910046Swift® Applicator TipsSWF-AT01-10SWF-AT01-102019-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935650621319HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621333HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621357HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621371HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622613HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622620HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622637HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622651HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622668HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622682HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622699HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622729HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650623344HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650623351HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650624327HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626048HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626451HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626468HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
05060359560971MicroBlate FineCREO MEDICAL LIMITEDNEY2025-05-05
05060359560490MicroBlate FineCREO MEDICAL LIMITEDNEY2025-05-05
06954414601015Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601022Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601039Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601046Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601053Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601060Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601077Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601084Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601107Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601121Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14