IRN · Device, Warning, Overload, External Limb, Powered
Physical Medicine · 21 CFR 890.5575 · Class 2
Overview
| Product Code | IRN |
|---|---|
| Device Name | Device, Warning, Overload, External Limb, Powered |
| Regulation | 21 CFR 890.5575 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload or an underload in the amount of pressure placed on a leg.
Classification Rationale
Class II (special 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.
Special Controls
*Classification.* Class II (special 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.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K060150 | SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM | Andante Medical Devices , Ltd. | Feb 23, 2006 | SESE |
| K023161 | SMARTSTEP SYSTEM | Andante Medical Device, Ltd. | Dec 10, 2002 | SESE |
| K991313 | ACCUTRED SHOE | Orthopedic Technology Research, Inc. | Jun 23, 1999 | SESE |
| K962591 | FOOT WEIGHT ALARM | Cleveland Medical Devices, Inc. | Dec 4, 1996 | SESE |
| K960307 | INDEX SHOE | Orthopedic Technology Research, Inc. | Jun 27, 1996 | SESE |
| K955034 | FORCEGUARD | Impact Monitors, Inc. | Apr 10, 1996 | SESE |
| K950656 | PED ALERT | Orbitec Technologies Corp. | Oct 25, 1995 | SESE |
| K931517 | SAFE-STEP | Lenjoy Engineering, Inc. | Mar 10, 1995 | SESE |
| K882974 | FORCE GUARD I | Boulder Impact Monitors, Inc. | Nov 4, 1988 | SESE |
| K792241 | PELIMIT | Colmed, Ltd. | Nov 30, 1979 | SESE |
| K770405 | OVERLOAD WARNING DEVICE | Synthes (Usa) | Mar 10, 1977 | SESE |
Top Applicants
- Orthopedic Technology Research, Inc. — 2 clearances
- Andante Medical Device, Ltd. — 1 clearance
- Andante Medical Devices , Ltd. — 1 clearance
- Boulder Impact Monitors, Inc. — 1 clearance
- Cleveland Medical Devices, Inc. — 1 clearance
