| Device |
orthosis, foot drop |
| Regulation Description |
Limb orthosis. |
| Definition |
Aid for drop foot or similar disorders which have a lack of ankle dorsiflexion. Indicated for foot raising paresis. |
| Physical State |
includes shoulder harness, optional waist belt, optional shoulder pad, an elastic cord assembly and a shoe harness |
| Technical Method |
uses an elastic cord from shoulder harness to foot to provide foot raising support |
| Target Area |
intended to help raise foot |
| Regulation Medical Specialty |
Physical Medicine |
| Review Panel |
Physical Medicine |
|---|
| Product Code | OHI |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Rehabilitation Devices
(DHT5B)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
890.3475
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
Yes
|
| Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile. |
|
Summary Malfunction
Reporting |
Eligible |
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
| If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
