FDA.reportPublic FDA data

STEPRITE

Primary DI
00867239000252
Brand
STEPRITE
Company
MEDHAB, LLC
Model
7
Catalog number
STEPRITE SIZE 4
Device description
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
Published
2019-09-23
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

Product Codes#

Code, Name table
CodeName
IKKSystem, Isokinetic Testing And Evaluation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKKSystem, Isokinetic Testing And EvaluationPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867239000252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867239000252008672390002528672390002520867239000252

GMDN Terms#

Term, Definition table
TermDefinition
Pressure monitoring insoleA battery-powered device intended to be worn against the sole of the foot to sense, measure, and transmit information regarding plantar pressure distribution for the biomechanical analysis of gait. It is typically a synthetic insole with integrated pressure sensors and a wireless transmitter, whereby pressure distribution data is intended to be transmitted to, and analysed with, an off-the-shelf tablet/smartphone/computer containing dedicated software; a battery charger may be included. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
107660874
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850023296009MyNotifi RxVersion 2MyNotifi RX - large2020-09-24
00850023296016MyNotifi RxVersion 2MyNotifi RX - medium2020-09-24
00850023296023MyNotifi RxVersion 2MyNotifi RX - small2020-09-24
00850023296276RPM2 Rx7 Size (0)Shoe insole size 0 (women 7.0 to 8.5) (men 5.0 to 2020-09-23
00850023296283RPM2 Rx7 Size (00)Shoe insole size 00 (women 3.0 to 6.5)2020-09-23
00850023296290RPM2 Rx7 Size (01)Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to2020-09-23
00850023296306RMP2 Rx7 Size (1)Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to2020-09-23
00850023296313RPM2 Rx7 Size (12)Shoe insole size (12) (women 9.0 to 10.5) (men 7.02020-09-23
00850023296320RPM2 Rx7 Size (2)Shoe insole size 2 (women 11.0 to 12.5) (men 9.0 t2020-09-23
00850023296337RPM2 Rx7 Size (2-3)Shoe insole size (2-3) (women 11.0 to 12.5) (men 92020-09-23
00850023296344RPM2 Rx7 Size (3)Shoe insole size 3 (women 13.0 to 15.0) (men 11.0 2020-09-23
00850023296351RPM2 Rx7 Size (4)Shoe insole size 4 (men 13.0 to 15.0)2020-09-23
00850023296085STEPRITE7 Size (4)Shoe insole size 4 (men 13.0 to 15.0)2020-09-24
00850023296030STEPRITE7 Size (00)Shoe insole size 00 (women 3.0 to 6.5)2020-09-23
00850023296047STEPRITE7 Size (0)Shoe insole size 0 (women 7.0 to 8.5) (men 5.0 to 2020-09-23
00850023296054STEPRITE7 Size (1)Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to2020-09-23
00850023296061STEPRITE7 Size (2)Shoe insole size 2 (women 11.0 to 12.5) (men 9.0 t2020-09-23
00850023296160STEPRITE7 Size (3)Shoe insole size 3 (women 13.0 to 15.0) (men 11.0 2020-09-23
00867239000207STEPRITE7STEPRITE 002019-09-23
00867239000214STEPRITE7STEPRITE SIZE 02019-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975343590010Upper Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590027Lower Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590034Gait Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590041Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590058Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590065Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590072Upper Limbs Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590089Upper Limbs Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590133Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590140Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590157Upper Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590171Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590188Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590195Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590201Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590218Gait Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590225Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590256Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590287Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590300Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
04041925006339PHS - XSmedica - Medizintechnik GmbHIKK2026-05-13
04041925006346PHS - Smedica - Medizintechnik GmbHIKK2026-05-13
04041925006353PHS - Mmedica - Medizintechnik GmbHIKK2026-05-13
04041925006360PHS - Lmedica - Medizintechnik GmbHIKK2026-05-13
04041925006377PHS - XLmedica - Medizintechnik GmbHIKK2026-05-13
B108660POMUS00R-GAITBTL INDUSTRIES LIMITEDIKK2026-03-19
09120077180250LEXOtyromotion GmbHIKK2026-03-12
06979351820015Upper Limb Rehabilitation Training SystemShanghai ZDROID Medical Technology Co.,Ltd.IKK2025-12-23
05061081950009LifeGlov and Lifehub SystemBIOLIBERTY LTDIKK2025-12-03
05061081950184LifeGlov and Lifehub SystemBIOLIBERTY LTDIKK2025-12-03