BRACE C.T.
FDA 510(k) clearance K831310 · decided 1983-05-16
Clearance details
- K-number
- K831310
- Device name
- BRACE C.T.
- Applicant
- Innovation Sports, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-22
- Decision date
- 1983-05-16
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- ITQ
- Device class
- 1
- Regulation number
- 890.3475
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LIMITED MOTION FUNCTIONAL KNEE BRACE (K831044) | Orthopedic Systems, Inc. | 1983-06-24 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.