Panels › Physical Medicine › Product code ISW · Class 2
Assembly, Knee/Shank/Ankle/Foot, External
Regulation 890.3500
0510(k)s in 12 months (1 all time)
0recalls in 12 months (10 all time)
0recalls that name a 510(k)
Top companies in ISW
| Company | 510(k)s | Recalls |
|---|---|---|
| Ossur H / F | 0 | 6 |
| Ability Dynamics LLC | 0 | 1 |
| iwalk inc | 0 | 1 |
| Ossur Americas | 0 | 1 |
| Otto Bock Healthcare Product | 0 | 1 |
| Otto Bock Orthopedic Industry, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2024 | Ossur H / F RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component Open, Classified |
ISW | None listed |
| May 10, 2024 | Ossur H / F RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component Open, Classified |
ISW | None listed |
| May 10, 2024 | Ossur H / F RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component Open, Classified |
ISW | None listed |
| May 10, 2024 | Ossur H / F RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component Open, Classified |
ISW | None listed |
| Jan 25, 2024 | Ossur H / F Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 Open, Classified |
ISW | None listed |
| Sep 28, 2022 | Ossur Americas OSSUR Power Knee REF PKA10003
OSSUR Power Knee REF PKA10003
OSSUR Power Knee REF PKA01001L
OSSUR Power Knee REF PKA01001T Open, Classified |
ISW | None listed |
| Aug 21, 2015 | Otto Bock Healthcare Product Otto Bock Healthcare Products GmbH Genium X3
Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH.
Intended to be used solely for lower limb prosthetic fittings. Terminated |
ISW | None listed |
| Mar 25, 2015 | Ossur H / F The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and envi Terminated |
ISW | None listed |
| Jun 18, 2014 | Ability Dynamics LLC RUSH81 Prosthetic Foot
Product Usage: Prosthetic foot for human use Terminated |
ISW | None listed |
| Dec 4, 2012 | iwalk inc BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system:
Product Number: 2001249 BiOM Battery
Product Number: 2001240 BiOM Charger Terminated |
ISW | None listed |
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