Product code ITQ
- Device name
- Joint, Knee, External Brace
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3475
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K831044 | LIMITED MOTION FUNCTIONAL KNEE BRACE | Orthopedic Systems, Inc. | 1983-06-24 |
| K831310 | BRACE C.T. | Innovation Sports, Inc. | 1983-05-16 |
| K823658 | DELUXE KNEE IMMOBILIZER(UNIVERSAL) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| K823397 | ANATOMIC FRACTURE BRACE | Orthopedic Systems, Inc. | 1982-11-29 |
| K823159 | DELUXE KNEE IMMOBILIZER | Warm & Form, Orthopedic Materials | 1982-11-10 |
| K812423 | NEOPRENE KNEE SUPPORT | Surgical Appliance Industries, Inc. | 1981-09-14 |
| K812094 | AIRCAST PNEUMATIC KNEE BRACE | Aircast, Inc. | 1981-08-13 |
| K811689 | CYLINDER KNEE CAST/SPLINT | Surgical Appliance Industries, Inc. | 1981-06-25 |
| K810222 | LIMB ORHTOSIS | Medical Design & Manufacturing Corp. | 1981-02-04 |
| K802673 | KNEE BRACE/STABILIZER | Omni Scientific, Inc. | 1980-11-12 |
| K780892 | FRACTURE BRACING | Hosmer Dorrance Corp. | 1978-06-13 |
| K772268 | DEMI-WALKER (REGULAR) | Med Fusion Systems, Inc. | 1977-12-20 |
| K772269 | SETUP WALKER ADJUSTABLE | Med Fusion Systems, Inc. | 1977-12-20 |
| K772270 | SETUP WALKER OVER TOILET CONSTRUC. | Med Fusion Systems, Inc. | 1977-12-20 |
| K772271 | WALKER FOLDING ADJUSTABLE | Med Fusion Systems, Inc. | 1977-12-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00057475210434 | BIOS Living | Thermor Ltd | 2023-03-31 |
| 00609271200180 | 16'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271610811 | "Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (small)" | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271610804 | "Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (x-large)" | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271610798 | "Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (large)" | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271610781 | "Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (medium)" | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271610774 | "Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (small)" | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271210806 | 20'' DLX 3-PANEL KNEE IMMOB | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271210608 | 20'' DLX 3-PANEL KNEE IMMOB | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271210509 | 20'' DLX 3-PANEL KNEE IMMOB | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271200395 | 20'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271200388 | 20'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271200371 | 20'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271200357 | 20'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271200333 | 20'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271200197 | 16'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271200173 | 16'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271200159 | 16'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271200135 | 16'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| G088DSKNEX0 | Panacea | Blake Manufacturing, Inc. | 2022-09-02 |
| 00049022997639 | Walgreens | WALGREEN CO. | 2020-05-18 |
| 00049022963429 | Walgreens | WALGREEN CO. | 2020-05-18 |
| 00049022963368 | Walgreens | WALGREEN CO. | 2020-05-18 |
| 00049022767966 | Walgreens | WALGREEN CO. | 2020-05-18 |
| 00049022767959 | Walgreens | WALGREEN CO. | 2020-05-18 |
| 00049022767942 | Walgreens | WALGREEN CO. | 2020-05-18 |
| 00049022997868 | Walgreens | WALGREEN CO. | 2020-05-14 |
| 00049022997653 | Walgreens | WALGREEN CO. | 2020-05-09 |
| 00049022754911 | Walgreens | WALGREEN CO. | 2020-05-09 |
| 00081832302067 | VIVE | VIVE HEALTH LLC | 2019-01-20 |