FDA.report

Healing Innovations

Primary DI
00860003483206
Brand
Healing Innovations
Company
Healing Innovations, Inc.
Model
RWC1000
Device description
robotic neurorehabilitation device for gait training and additional therapy purposes
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

Related Records

Product Codes

CodeName
IKKSystem, Isokinetic Testing And Evaluation

Product Code Classifications

CodeDeviceSpecialtyClass
IKKSystem, Isokinetic Testing And EvaluationPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860003483206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003483206008600034832068600034832060860003483206

GMDN Terms

TermDefinition
Gait rehabilitation frame, electricAn electrically-powered, body-weight unloading, gait rehabilitation device designed to assist a patient with a walking/balance disability (neurogenic, muscular, or osseous in origin) regain lost motor function, by enabling them to hang in a dedicated harness in a vertical position and exercise (e.g., walk over the ground or moving surface of an elliptical/treadmill, climb stairs, perform sit-to-stand movements). It consists of a ceiling- or wall-mounted beam, or floor-standing frame with a motorized attachment assembly connected to the harness which supports the body weight. It is intended to be used in a clinical setting under professional supervision.

Sterilization Methods

Method

Regulatory Flags

DUNS number
071390002
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
true
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 Sharing Product Codes

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