FDA.reportPublic FDA data

RPM2 Rx

Primary DI
00850023296337
Brand
RPM2 Rx
Company
MEDHAB, LLC
Model
7 Size (2-3)
Catalog number
Shoe insole size (2-3) (women 11.0 to 12.5) (men 9
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
2020-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850023296337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850023296337008500232963378500232963370850023296337

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
Premarket exempt
true
Lot or batch
true
Serial number
true

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
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
00867239000221STEPRITE7STEPRITE SIZE 12019-09-23

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