Panels › Physical Medicine › Product code ITW · Class 1
Joint, Ankle, External Brace
Regulation 890.3475
0510(k)s in 12 months (1 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in ITW
| Company | 510(k)s | Recalls |
|---|---|---|
| Ossur H / F | 0 | 2 |
| Fred Sammons, Inc. | 1 | 0 |
| United Surgical Associates | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2016 | Ossur H / F Rebound Diabetic Walker
Product Usage:
Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers. Terminated |
ITW | None listed |
| Feb 24, 2016 | Ossur H / F Rebound Air Walker
Product Usage:
Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use. Terminated |
ITW | None listed |
| May 23, 2015 | United Surgical Associates Elastic Ankle Support.
A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align b Terminated |
ITW | None listed |
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