FDA.reportPublic FDA data

ACCUNIQ

Primary DI
08805116000157
Brand
ACCUNIQ
Company
SELVAS Healthcare, Inc.
Model
ACCUNIQ BC310
Published
2019-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNWAnalyzer, Body Composition

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNWAnalyzer, Body CompositionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140045000BODY COMPOSITION ANALYZERJawon Medical Co., Ltd.2015-02-18MNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08805116000157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08805116000157088051160001578805116000157

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical body composition analyserAn electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82428793024daisy.j.yoon@selvashc.com

Regulatory Flags#

DUNS number
689700711
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08805116000645ACCUNIQACCUNIQ BC7302025-07-25
08805116000560ACCUNIQACCUNIQ BC3902024-08-29
08805116000119ACCUNIQACCUNIQ BC7202019-02-01
08805116000133ACCUNIQACCUNIQ BC3802019-02-01
08805116000140ACCUNIQACCUNIQ BC3602019-02-01
08805116000164ACCUNIQACCUNIQ BC3002019-02-01
08805116000454ACCUNIQEV3602021-09-09
08805116000300ACCUNIQACCUNIQ BP2102019-02-01
08805116000317ACCUNIQACCUNIQ BP2502019-02-01
08805116000379ACCUNIQACCUNIQ BP8502019-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04904785198449Body Composition AnalyzerTANITA CORPORATIONMNW2025-10-24
04904785230491Body Composition AnalyzerTANITA CORPORATIONMNW2025-10-24
08809209592260InBodyInBody Co., Ltd.MNW2025-10-03
08809209592277InBodyInBody Co., Ltd.MNW2025-10-03
00077784049198TAYLORTAYLOR PRECISION PRODUCTS, INC.MNW2025-05-06
20077784049192TAYLORTAYLOR PRECISION PRODUCTS, INC.MNW2025-05-06
08809209590969InBodyInBody Co., Ltd.MNW2024-07-23
00074108499714ConairCONAIR CORPORATIONMNW2024-05-13
B322F0011ES-BC LD TECHNOLOGY, LLCMNW2024-03-05
00875011004121Weight GurusGreater GoodsMNW2024-02-22
00074108356581CONAIRCONAIR CORPORATIONMNW2024-01-15
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08809209590976InBodyInBody Co., Ltd.MNW2023-06-22
08809209591676InBodyInBody Co., Ltd.MNW2023-06-22
08809209591683InBodyInBody Co., Ltd.MNW2023-06-22
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00074108317216CONAIRCONAIR CORPORATIONMNW2023-04-30
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00694501121786SunbeamStar Elite IncMNW2023-01-17
00074108278043Conair CONAIR CORPORATIONMNW2022-12-05
00074108313874CONAIRCONAIR CORPORATIONMNW2022-11-28
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