FDA.reportPublic FDA data

HoMedics

Primary DI
00031262113733
Brand
HoMedics
Company
FKA DISTRIBUTING CO., LLC
Model
BM-IS500J
Device description
Compact Inversion back stretcher
Published
2024-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
INWTable, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INWTable, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00031262113733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00031262113733000312621137330312621137330031262113733

GMDN Terms#

Term, Definition table
TermDefinition
Inversion tableA fixed framework with a tilting table platform designed to support the body of a patient and provide traction for the back muscles and spine by allowing the patient manually invert their entire body in a supine position (feet up and head down). The patient locks their feet behind a cross-member or in straps and leans backwards, pivoting the table on a central pivot, to decompress the spine by diminishing the influence of gravity and allowing the muscles and ligaments that encase the spine to relax; it may also help increase the space between the vertebrae. This device can be used in a healthcare facility or in the home to assist patients eliminate/alleviate back pain.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
183280973
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015688927HomedicsTIE-050-BABY2026-05-31
00031262100207HOMEDICSHP-G42AJ2020-08-31
00031262114938HOMEDICSSR-GA800J-WMT2024-06-20
00031262114945HOMEDICS SR-GHD800J-WMT2024-06-20
00031262114952HOMEDICS SR-GKM800J-WMT2024-06-20
00031262111975HOMEDICSSR-GHN800J2024-05-01
00031262111982HOMEDICS SR-GHD800J2024-05-01
00031262112002HOMEDICSSR-GA800J2024-05-01
00031262112026HOMEDICSSR-GEM700J2024-05-01
00031262112088HOMEDICSSR-GKM800J2024-05-01
00031262115874HomedicsSCL-XBC200-BK2025-01-25
00031262115898HomedicsSCL-XBC200-WT2025-01-25
00031262115904HomedicsSCL-BBC200-BK2025-01-25
00031262115911HomedicsSCL-BBC200-WT2025-01-25
00031262115959HomedicsSCL-BBC250-BK2025-01-25
00031262115966HomedicsSCL-BBC250-WT2025-01-25
00031262115997HomedicsSCL-BBC350-BK2025-01-25
00031262116000HomedicsSCL-BBC350-WT2025-01-25
00031262111753HomedicsIFR-95HJ2024-10-31
00031262114518HomedicsIFR-99HJ2024-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972077026532PROHEALXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026563PROHEALXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026570PROHEALXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026594SPECIALTYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026600SPECIALTYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026617SPECIALTYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026624SPECIALTYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026631CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026648CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026655JOYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026662JOYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
00815235022617UMF MedicalUNITED METAL FABRICATORS, INC.INW2026-05-14
06972077026433ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026440ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026549ProactiveXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026556PROHEALXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026259EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026280EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026297EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026303EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026761EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026778EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026174CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
06972077026181CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
06972077026211CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
06972077026310ProactiveXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
05715393022809R82R82 A/SINW2026-01-20
05715393022816R82R82 A/SINW2026-01-20
05715393022823R82R82 A/SINW2026-01-20
05715393022830R82R82 A/SINW2026-01-20