Identity
- Trade Name
- Reflex FDA UDI
- Generic Name
- Virtual-display rehabilitation system, non-supportive, home-use FDA UDI
- Device Name
- Reflex is a rehabilitative exercise device that fits to the lower limb and is intended to facilitate knee stretching and strengthening exercises and perform measurement functions for rehabilitation related to musculoskeletal pathologies, injury, and/or surgery of the knee. Reflex is intended to be used in a clinical or home environment. FDA UDI
- Model / Reference
- KN33-LE FDA UDI
- Description
- Reflex is a rehabilitative exercise device that fits to the lower limb and is intended to facilitate knee stretching and strengthening exercises and perform measurement functions for rehabilitation related to musculoskeletal pathologies, injury, and/or surgery of the knee. Reflex is intended to be used in a clinical or home environment. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860013061104 FDA UDI
- FDA Product Code
- IKK FDA UDI
- GMDN Term
- Virtual-display rehabilitation system, non-supportive, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1925 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
No
FDA UDI
Category: Virtual-display rehabilitation system, non-supportive, home-use
Reflex by Assistive Technology Development, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Assistive Technology Development, Inc.
Sources (1)
- FDA UDI 045e54e5-3006-49d3-9db8-a72b95e53a2b 33 fields · synced May 31, 2026