R-GAIT

GUDID B108660POMUS00

Treadmill/elliptical gait rehabilitation system

Primary Device ID	B108660POMUS00
NIH Device Record Key	c2e1a06a-b8d0-4228-85a3-6b17f7b3e50c
Commercial Distribution Status	In Commercial Distribution
Brand Name	R-GAIT
Version Model Number	R-GAIT
Company DUNS	733532951
Company Name	BTL INDUSTRIES LIMITED
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B108660POMUS00 [Primary]

IKK	System, Isokinetic Testing And Evaluation

Steralize Prior To Use	false
Device Is Sterile	false