Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- PHLPowered Exoskeleton2Product Code
- K250904Atalante X2Cleared 510(K)
- K241822ReWalk® 7 Personal Exoskeleton (50-20-0005)2Cleared 510(K)
- K233695Medical HAL Lower Limb Type (HAL-ML)2Cleared 510(K)
- K232077Atalante X2Cleared 510(K)
- K221696ReWalk P6.02Cleared 510(K)
- K221859Atalante2Cleared 510(K)
- K220988EksoNR2Cleared 510(K)
- K213452GEMS-H2Cleared 510(K)
- K201473ExoAtlet-II2Cleared 510(K)
- K201559HAL for Medical Use(Lower Limb type)2Cleared 510(K)
- K201539Keeogo Dermoskeleton System2Cleared 510(K)
- K200574EksoNR2Cleared 510(K)
- K200032ReWalk P6.02Cleared 510(K)
- K190337ReWalk Restore2Cleared 510(K)
- K183152Phoenix2Cleared 510(K)
- K181294Honda Walking Assist Device2Cleared 510(K)
- K173530Indego(R)2Cleared 510(K)
- K171909HAL for Medical Use (Lower Limb Type)2Cleared 510(K)
- K171334Indego2Cleared 510(K)
- K160987ReWalk(TM)2Cleared 510(K)
- K161443Ekso™ (version 1.1) and Ekso GT™ (version 1.2)2Cleared 510(K)
- K143690Ekso™ (version 1.1) and Ekso GT™ (version 1.2)2Cleared 510(K)
- K152416Indego2Cleared 510(K)
- DEN130034REWALK2Cleared 510(K)
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ReWalk Restore
- Page Type
- Cleared 510(K)
- 510(k) Number
- K190337
- 510(k) Type
- Traditional
- Applicant
- ReWalk Robotics Ltd.
- Country
- Israel
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/3/2019
- Days to Decision
- 109 days
- Submission Type
- Summary