510(k) K960307
- Device
- INDEX SHOE
- Applicant
- ORTHOPEDIC TECHNOLOGY RESEARCH, INC.
- 510(k) number
- K960307
- Product code
- IRN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-06-27
- Date received
- 1996-01-22
- Regulation
- 890.5575
- Classification name
- Device, Warning, Overload, External Limb, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRIAN T CLEARY
- Address
- 819 W. Stryker Ave. Suite 10 Sacramento CA US 95834 95834
FDA Registration Numbers#
- 3009757062
Source Documents#
Other 510(k) Records For Product Code IRN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060150 | SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM | Andante Medical Devices , Ltd. | 2006-02-23 |
| K023161 | SMARTSTEP SYSTEM | Andante Medical Device, Ltd. | 2002-12-10 |
| K991313 | ACCUTRED SHOE | Orthopedic Technology Research, Inc. | 1999-06-23 |
| K962591 | FOOT WEIGHT ALARM | Cleveland Medical Devices, Inc. | 1996-12-04 |
| K955034 | FORCEGUARD | Impact Monitors, Inc. | 1996-04-10 |
| K950656 | PED ALERT | Orbitec Technologies Corp. | 1995-10-25 |
| K931517 | SAFE-STEP | Lenjoy Engineering, Inc. | 1995-03-10 |
| K882974 | FORCE GUARD I | Boulder Impact Monitors, Inc. | 1988-11-04 |
| K792241 | PELIMIT | Colmed, Ltd. | 1979-11-30 |
| K770405 | OVERLOAD WARNING DEVICE | Synthes (Usa) | 1977-03-10 |
Legacy Summary#
summary
FDA Review#
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