FDA.report

Toe separator

Definition
A foot-worn device designed to space the toes of the foot to relieve pain, pressure/friction between toes, and/or to facilitate realignment of the toes to a natural position. It is made of soft materials (e.g., silicone, polymer gel) and may be available in a variety of forms (e.g., circular channels moulded together, small disks, half moon shape); some types are in addition intended to protect and/or reduce bunion or Tailor’s bunion formation. This is a reusable device.
GUDID devices
59
Last updated
2025-05-28 08:47:03

Related Product Codes

CodeDeviceSpecialtyClassDevices
FMPProtector, Skin PressureGeneral Hospital138
KYSInsoles, MedicalGeneral Hospital18
NOCSplint, Extremity, Non-Inflatable, External, Non-SterileGeneral, Plastic Surgery16
OHIOrthosis, Foot DropPhysical Medicine16
KNPOrthosis, Corrective ShoePhysical Medicine11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
10810041981858ViveSoleVIVE HEALTH LLCINS1044WHT2025-05-20
00050428287798CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATED3345632020-06-18
00050428419670CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATED6876372020-06-18
50050428271860CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATED7892702020-06-18
50050428330390CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATED5406502020-06-18
50050428347213CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATED7892762020-06-18
50050428361523CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATED3345602020-06-18
50050428341846CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATED5484342020-06-18
08431082070391ComforsilPRIM S.A.CC218M2024-03-08
08431082070810ComforsilPRIM S.A.CC206S2024-03-08
08431082070827ComforsilPRIM S.A.CC206M2024-03-08
08431082070834ComforsilPRIM S.A.CC206L2024-03-08
08431082070841ComforsilPRIM S.A.CC218S2024-03-08
08431082070858ComforsilPRIM S.A.CC218L2024-03-08
10041298993862SteinsD-M-S HOLDINGS, INC.765-3080-00002024-02-02
00194346136155equateWAL-MART STORES, INC.WMTBUN-100J2024-01-22
10810113575473ViveVIVE HEALTH LLCINS1059BLUS2024-01-12
10810113575480ViveVIVE HEALTH LLCINS1059BLUM2024-01-12
10810113575497ViveVIVE HEALTH LLCINS1059BLUL2024-01-12
00713733074940MEIJERMEIJER, INC.007137330749402023-03-08
10609271039961DARCO® Toe-Alignment Splint™DARCO INTERNATIONAL, INC.TAS2023-02-08
20609271031153DARCO® GTS™ Great Toe SplintDARCO INTERNATIONAL, INC.GTS1L2023-02-08
20609271031351DARCO® GTS™ Great Toe SplintDARCO INTERNATIONAL, INC.GTS2L2023-02-08
20609271032150DARCO® GTS™ Great Toe SplintDARCO INTERNATIONAL, INC.GTS1R2023-02-08
20609271032358DARCO® GTS™ Great Toe SplintDARCO INTERNATIONAL, INC.GTS2R2023-02-08
14251853900150DARCO® TAS™ (Toe Alignment Splint)DARCO INTERNATIONAL, INC.TAS-222023-02-08
00614464042898Softzone Gel Toe Separator, Large, Wide, Bulk, 100pcs/bagSilipos Holding LLC42892022-08-24
00610570034581TOE SPREADER SM 12/PKBird & Cronin, LLC484581222022-08-20
00610570034635TOE CREST PAD SM LT 3/PKBird & Cronin, LLC484581522022-08-20
00610570034642TOE CREST PAD MD LT 3/PKBird & Cronin, LLC484581532022-08-20
00610570034680TOE CREST PAD SM RT 3/PKBird & Cronin, LLC484581622022-08-20
00614464015878Therast Polybag Cushion Toe Spreaders Medium 4/Pkg.Silipos Holding LLC15872022-08-05
00614464065088Antibacterial Gel Toe Spreader, Small, 6pcs/bagSilipos Holding LLC65082022-08-05
00614464065095Antibacterial Gel Toe Spreader, Medium, 6pcs/bagSilipos Holding LLC65092022-08-05
00614464065101Antibacterial Gel Toe Spreader, Large, 6pcs/bagSilipos Holding LLC65102022-08-05
00614464065118Antibacterial Gel Toe Separator, Small, 6pcs/bagSilipos Holding LLC65112022-08-05
00614464065125Antibacterial Gel Toe Separators, Large 6pcs/bagSilipos Holding LLC65122022-08-05
00614464070020Therastep Gel Toe Spacers, 2pcs/blisterSilipos Holding LLC70022022-08-05
00614464070037Therastep Gel Toe Separators, 2pcs/blisterSilipos Holding LLC70032022-08-05
00614464070228Therastep Gel Toe Spacers, 1pc/blisterSilipos Holding LLC70222022-08-05
00614464070525Therastep Gel Toe Spacers, French/English, 2pcs/blisterSilipos Holding LLC70522022-08-05
00614464070532"Therastep Gel Toe Separators, French/English, 2pcs/blister "Silipos Holding LLC70532022-08-05
00614464072079"Active Gel Toe Spacers, 2pcs/blister "Silipos Holding LLC72072022-08-05
00614464072086Active Gel Toe Separators, 2pc/blisterSilipos Holding LLC72082022-08-05
00614464115059Gel Toe Spreader, Small, 4pcs/bagSilipos Holding LLC115052022-08-05
00614464115158Gel Toe Spreader, Medium, 4pcs/bagSilipos Holding LLC115152022-08-05
00614464115257Gel Toe Spreader, Large, 4pcs/bagSilipos Holding LLC115252022-08-05
00614464116056Gel Toe Separator, Small, 15pcs/bagSilipos Holding LLC116052022-08-05
00614464116155Gel Toe Separator, Large, 15pcs/bagSilipos Holding LLC116152022-08-05
00614464315053Gel Toe Spreader, Small, Bulk, 100pcs/bagSilipos Holding LLC315052022-08-05
00614464315152Gel Toe Spreader, Medium, Bulk, 100pcs/bagSilipos Holding LLC315152022-08-05
00614464315251Gel Toe Spreader, Large, Bulk, 100pcs/bagSilipos Holding LLC315252022-08-05
00614464316050Gel Toe Separator, Small, Bulk, 100pcs/bagSilipos Holding LLC316052022-08-05
00614464316159Gel Toe Separator, Large, Bulk, 100pcs/bagSilipos Holding LLC316152022-08-05
10810041981964VIVEVIVE HEALTH LLCINS10442020-04-23
10818323020837VIVEVIVE HEALTH LLCINS1033WHT2019-01-30
10818323026051VIVEVIVE HEALTH LLCINS1014GRN2019-01-29
10818323026068VIVEVIVE HEALTH LLCINS10152019-01-29
10818323026075VIVEVIVE HEALTH LLCINS10172019-01-29