ITQ
15 FDA 510(k) clearances · Product code
16 daysmedian time to decision
24 days90th percentile
15clearances measured
FDA profile
- Official device name
- Joint, Knee, External Brace
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2018: 12 · 2019: 76 · 2020: 22 · 2023: 75 · 2024: 110 · 2025: 45
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LIMITED MOTION FUNCTIONAL KNEE BRACE (K831044) | Orthopedic Systems, Inc. | 1983-06-24 |
| BRACE C.T. (K831310) | Innovation Sports, Inc. | 1983-05-16 |
| DELUXE KNEE IMMOBILIZER(UNIVERSAL) (K823658) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| ANATOMIC FRACTURE BRACE (K823397) | Orthopedic Systems, Inc. | 1982-11-29 |
| DELUXE KNEE IMMOBILIZER (K823159) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| NEOPRENE KNEE SUPPORT (K812423) | Surgical Appliance Industries, Inc. | 1981-09-14 |
| AIRCAST PNEUMATIC KNEE BRACE (K812094) | Aircast, Inc. | 1981-08-13 |
| CYLINDER KNEE CAST/SPLINT (K811689) | Surgical Appliance Industries, Inc. | 1981-06-25 |
| LIMB ORHTOSIS (K810222) | Medical Design & Manufacturing Corp. | 1981-02-04 |
| KNEE BRACE/STABILIZER (K802673) | Omni Scientific, Inc. | 1980-11-12 |
| FRACTURE BRACING (K780892) | Hosmer Dorrance Corp. | 1978-06-13 |
| DEMI-WALKER (REGULAR) (K772268) | Med Fusion Systems, Inc. | 1977-12-20 |
| SETUP WALKER OVER TOILET CONSTRUC. (K772270) | Med Fusion Systems, Inc. | 1977-12-20 |
| SETUP WALKER ADJUSTABLE (K772269) | Med Fusion Systems, Inc. | 1977-12-20 |
| WALKER FOLDING ADJUSTABLE (K772271) | Med Fusion Systems, Inc. | 1977-12-20 |
Track ITQ automatically
Every clearance here is in the API, with alerts when new ones post.