FDA.reportPublic FDA data

StepWatch

Primary DI
00860007307515
Brand
StepWatch
Company
Modus Health LLC
Model
StepWatch5
Published
2023-09-08
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
00860007307515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007307515008600073075158600073075150860007307515

GMDN Terms#

Term, Definition table
TermDefinition
Kinesiology ambulatory recorderA battery-powered device designed to continuously measure and record a patient's kinetic activity during routine ambulation, including monitoring the motion of individual joints/limbs, typically to assess joint mobility, gait performance, and fall-risk or frailty (e.g., during post-surgery rehabilitation). It consists of a motion sensor(s) worn on the torso or a limb (e.g., thigh, calf, wrist, ankle) while performing normal daily activities, and a computing device/software to which body movement signals are transmitted for recording/analysis; it may also be attached to or integrated in an external limb prosthesis for activity monitoring.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078855932
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007307522StepWatchStepWatch42021-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810188050021Bioness Integrated System (BITS) Bedside ConfigurationBioness Medical, Inc.IKK2025-07-18
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBioness Medical, Inc.IKK2025-07-18
00810188050038Bioness Integrated System (BITS) Mobile ConfigurationBioness Medical, Inc.IKK2025-07-17
08809209591980InBodyInBody Co., Ltd.IKK2025-05-09
00860013061104ReflexAssistive Technology Development, Inc.IKK2025-04-23
04041925006117PHS - XSmedica - Medizintechnik GmbHIKK2024-11-14
04041925006124PHS - Smedica - Medizintechnik GmbHIKK2024-11-14
04041925006131PHS - Mmedica - Medizintechnik GmbHIKK2024-11-14
04041925006148PHS - Lmedica - Medizintechnik GmbHIKK2024-11-14
04041925006155PHS - XLmedica - Medizintechnik GmbHIKK2024-11-14
00860002828749PortableConnectRom Technologies, Inc.IKK2024-03-20
00628719321003Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321010Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321027Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321034Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321041Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321058Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321065Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321072Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00840216113978PRIMOAsp Global, LLCIKK2023-11-15
08800101600183rebless (Model: RHDB)H ROBOTICS INC.IKK2023-10-30
04041925002775THERA-Trainer lyramedica - Medizintechnik GmbHIKK2023-10-23
07640174660353ArmeoHOCOMA AGIKK2023-10-11
07640174660377ManovoHOCOMA AGIKK2023-10-11
07640174660391ArmeoHOCOMA AGIKK2023-10-11