FDA UDI
In Commercial Distribution
🇺🇸 United States
Reflex
DI: 00860013061104
·
Model: KN33-LE
·
Assistive Technology Development, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Reflex
- Primary DI
- 00860013061104
- Version / Model
- KN33-LE
- Company Name
- Assistive Technology Development, Inc.
- Labeler DUNS
- 119319634
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-23
- Public Version
- 1
- Public Version Date
- 2025-05-01
- Public Version Status
- New
- Public Device Record Key
- 045e54e5-3006-49d3-9db8-a72b95e53a2b
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | Physical Medicine | 890.1925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60926 | Virtual-display rehabilitation system, non-supportive, home-use | An assembly of devices intended to be used both in a home and clinical setting and to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back, trunk, and/or limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement; it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., patient-worn infrared (IR) glove, motion tracking heel pad or camera, software] that communicate to provide a virtual-display interface. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860013061104 | GS1 |