Device, Warning, Overload, External Limb, Powered
A powered external limb overload warning device is a safety component integrated into powered prosthetic systems that detects and signals excessive force or torque conditions to prevent damage to the device or injury to the user. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IRN, regulated under 21 CFR 890.5575, within the Physical Medicine medical specialty.
Research product code IRN in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- IRN
- Device Class
- FDA class 2
- Regulation Number
- 890.5575
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K060150 | SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM | Feb 23, 2006 | Substantially Equivalent | Andante Medical Devices , Ltd. |
| K023161 | SMARTSTEP SYSTEM | Dec 10, 2002 | Substantially Equivalent | Andante Medical Device, Ltd. |
| K991313 | ACCUTRED SHOE | Jun 23, 1999 | Substantially Equivalent | Orthopedic Technology Research, Inc. |
| K962591 | FOOT WEIGHT ALARM | Dec 04, 1996 | Substantially Equivalent | Cleveland Medical Devices, Inc. |
| K960307 | INDEX SHOE | Jun 27, 1996 | Substantially Equivalent | Orthopedic Technology Research, Inc. |
| K955034 | FORCEGUARD | Apr 10, 1996 | Substantially Equivalent | Impact Monitors, Inc. |
| K950656 | PED ALERT | Oct 25, 1995 | Substantially Equivalent | Orbitec Technologies Corp. |
| K931517 | SAFE-STEP | Mar 10, 1995 | Substantially Equivalent | Lenjoy Engineering, Inc. |
| K882974 | FORCE GUARD I | Nov 04, 1988 | Substantially Equivalent | Boulder Impact Monitors, Inc. |
| K792241 | PELIMIT | Nov 30, 1979 | Substantially Equivalent | Colmed, Ltd. |
| K770405 | OVERLOAD WARNING DEVICE | Mar 10, 1977 | Substantially Equivalent | Synthes (Usa) |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.