IRN — Device, Warning, Overload, External Limb, Powered Class II
FDA product code IRN covers "Device, Warning, Overload, External Limb, Powered", a Class II medical device regulated under 21 CFR 890.5575. Submissions are reviewed by the Physical Medicine panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IRN
- Device Class
- Class II
- Regulation Number
- 890.5575
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K060150 | andante medical devices | SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM | February 23, 2006 |
| K023161 | andante medical device | SMARTSTEP SYSTEM | December 10, 2002 |
| K991313 | orthopedic technology research | ACCUTRED SHOE | June 23, 1999 |
| K962591 | cleveland medical devices | FOOT WEIGHT ALARM | December 4, 1996 |
| K960307 | orthopedic technology research | INDEX SHOE | June 27, 1996 |
| K955034 | impact monitors | FORCEGUARD | April 10, 1996 |
| K950656 | orbitec technologies | PED ALERT | October 25, 1995 |
| K931517 | lenjoy engineering | SAFE-STEP | March 10, 1995 |
| K882974 | boulder impact monitors | FORCE GUARD I | November 4, 1988 |
| K792241 | colmed | PELIMIT | November 30, 1979 |
| K770405 | synthes (usa) | OVERLOAD WARNING DEVICE | March 10, 1977 |