ITQ · Joint, Knee, External Brace
Physical Medicine · 21 CFR 890.3475 · Class 1
Overview
| Product Code | ITQ |
|---|---|
| Device Name | Joint, Knee, External Brace |
| Regulation | 21 CFR 890.3475 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
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 body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K831044 | LIMITED MOTION FUNCTIONAL KNEE BRACE | Orthopedic Systems, Inc. | Jun 24, 1983 | SESE |
| K831310 | BRACE C.T. | Innovation Sports, Inc. | May 16, 1983 | SESE |
| K823658 | DELUXE KNEE IMMOBILIZER(UNIVERSAL) | Warm & Form, Orthopedic Materials | Dec 30, 1982 | SESE |
| K823397 | ANATOMIC FRACTURE BRACE | Orthopedic Systems, Inc. | Nov 29, 1982 | SESE |
| K823159 | DELUXE KNEE IMMOBILIZER | Warm & Form, Orthopedic Materials | Nov 10, 1982 | SESE |
| K812423 | NEOPRENE KNEE SUPPORT | Surgical Appliance Industries, Inc. | Sep 14, 1981 | SESE |
| K812094 | AIRCAST PNEUMATIC KNEE BRACE | Aircast, Inc. | Aug 13, 1981 | SESE |
| K811689 | CYLINDER KNEE CAST/SPLINT | Surgical Appliance Industries, Inc. | Jun 25, 1981 | SESE |
| K810222 | LIMB ORHTOSIS | Medical Design & Manufacturing Corp. | Feb 4, 1981 | SESE |
| K802673 | KNEE BRACE/STABILIZER | Omni Scientific, Inc. | Nov 12, 1980 | SESE |
| K780892 | FRACTURE BRACING | Hosmer Dorrance Corp. | Jun 13, 1978 | SESE |
| K772271 | WALKER FOLDING ADJUSTABLE | Med Fusion Systems, Inc. | Dec 20, 1977 | SESE |
| K772270 | SETUP WALKER OVER TOILET CONSTRUC. | Med Fusion Systems, Inc. | Dec 20, 1977 | SESE |
| K772269 | SETUP WALKER ADJUSTABLE | Med Fusion Systems, Inc. | Dec 20, 1977 | SESE |
| K772268 | DEMI-WALKER (REGULAR) | Med Fusion Systems, Inc. | Dec 20, 1977 | SESE |
Top Applicants
- Med Fusion Systems, Inc. — 4 clearances
- Orthopedic Systems, Inc. — 2 clearances
- Surgical Appliance Industries, Inc. — 2 clearances
- Warm & Form, Orthopedic Materials — 2 clearances
- Aircast, Inc. — 1 clearance
