Identity
- Trade Name
- Ovation 700 FDA UDI
- Generic Name
- Gait rehabilitation frame, electric FDA UDI
- Device Name
- The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. Ovation should never be used to lift subjects off the ground and should never be connected to inanimate objects. Ovation should only be operated by clinicians and trained healthcare professionals who have read and understand the instructions for use and have passed the Ovation training competency exam conducted by an Aretech trainer or a certified staff trainer. The Ovation 700 model allows for a patient weight capacity of up to 700 pounds with a dynamic body-weight support range of 25 to 300 pounds. FDA UDI
- Model / Reference
- OV-700 FDA UDI
- Description
- The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. Ovation should never be used to lift subjects off the ground and should never be connected to inanimate objects. Ovation should only be operated by clinicians and trained healthcare professionals who have read and understand the instructions for use and have passed the Ovation training competency exam conducted by an Aretech trainer or a certified staff trainer. The Ovation 700 model allows for a patient weight capacity of up to 700 pounds with a dynamic body-weight support range of 25 to 300 pounds. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850018836043 FDA UDI
- FDA Product Code
- BXB FDA UDI
- GMDN Term
- Gait rehabilitation frame, electric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5380 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gait rehabilitation frame, electric
Ovation 700 by Aretech, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gait rehabilitation frame, electric.
- Vector Gait and Safety System — Bioness Medical, Inc. · Class I
- SafeGait 360 Balance and Mobility Trainer — DIH TECHNOLOGY INC. · Class I
- SafeGait Active 360 Dynamic Mobility Trainer — DIH TECHNOLOGY INC. · Class I
- Healing Innovations — HEALING INNOVATIONS · Class II
- Vector Elite — BIONESS INC. · Class I
- Vector Elite — BIONESS INC. · Class I
- SafeGait Active Dynamic Mobility Trainer — DIH TECHNOLOGY INC. · Class I
- ZeroG-Lite Treadmill System — ARETECH, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aretech, Llc
Sources (1)
- FDA UDI 21df7621-1a9c-4ec1-9b23-c60229957963 34 fields · synced May 31, 2026