FDA.report

TERRAILLON

Primary DI
03094570147101
Brand
TERRAILLON
Company
TERRAILLON
Model
15052
Device description
MASTER FIT - GLASS DIGITAL BODY FAT SCALE
Published
2021-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
PUHAnalyzer, Body Composition, Exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PUHAnalyzer, Body Composition, ExemptCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03094570147101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03094570147101030945701471013094570147101

GMDN Terms

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

Regulatory Flags

DUNS number
281741801
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03094570144575TERRAILLON150412021-08-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08809209592321InBodyInBody Co., Ltd.PUH2026-02-28
00810079250042Teladoc Health, Inc.Teladoc Health, Inc.PUH2026-02-17
00810079250059Teladoc Health, Inc.Teladoc Health, Inc.PUH2026-02-17
10810140062908RENPHOJoicom CorporationPUH2026-01-04
00050428005804CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPUH2025-12-10
10810140062847RENPHOJoicom CorporationPUH2025-11-25
04904785198456Body Composition AnalyzerTANITA CORPORATIONPUH2025-09-22
14719846016504CharderCHARDER ELECTRONIC CO., LTD.PUH2025-08-12
04719846016484CharderCHARDER ELECTRONIC CO., LTD.PUH2025-08-11
04719846016088CharderCHARDER ELECTRONIC CO., LTD.PUH2025-08-07
08805116000645ACCUNIQSELVAS Healthcare, Inc.PUH2025-07-25
10810140062571RENPHOJoicom CorporationPUH2025-07-22
10810140062557RENPHOJoicom CorporationPUH2025-06-26
10810140062519RENPHOJoicom CorporationPUH2025-06-12
04012030022026seca mBCA 545seca GmbH & Co. KGPUH2025-05-01
04012030022033seca mBCA 542seca GmbH & Co. KGPUH2025-05-01
04012030022910seca analytics 125seca GmbH & Co. KGPUH2025-04-30
16928081771378arboleafShenzhen Yolanda Technology Co.,Ltd.PUH2025-04-14
16928081771361arboleafShenzhen Yolanda Technology Co.,Ltd.PUH2025-04-13
10810140062403RENPHOJoicom CorporationPUH2025-03-11
10810140062410RENPHOJoicom CorporationPUH2025-03-11
10810140062335RENPHOJoicom CorporationPUH2025-02-21
00031262115874HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115898HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115904HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115911HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115959HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115966HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115997HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262116000HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25