510(k) K894283
- Device
- COMPREHENSIVE SPINE MOTION ANALYZER
- Applicant
- ORTHOPEDIC SYSTEMS, INC.
- 510(k) number
- K894283
- Product code
- KQX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-01-19
- Date received
- 1989-06-23
- Regulation
- 888.1500
- Classification name
- Goniometer, Ac-powered
- Medical specialty
- Orthopedic
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT MOORE
- Address
- 1897 National Ave. Hayward CA US 94545 94545
FDA Registration Numbers#
- 3011410128
- 3025421686
- 3015316271
- 3016851379
- 3016711710
- 1220246
- 3011466827
- 3017264244
- 3027518284
- 3010872373
- 3029957137
- 3027285894
- 1933956
- 3014848734
- 3009044218
- 1816267
- 9616494
- 3022115591
- 3015060244
- 3013846070
- 3004904656
- 8021957
- 3017723982
- 3033509895
- 3015542970
- 3013729860
- 3025591939
- 3004905643
- 3009718162
- 3013687630
- 3034089185
- 3022375812
- 3006644670
- 3003890514
- 3023744170
- 2084126
- 2133840
- 3015802419
- 3005868392
- 3010303097
- 3015766032
- 3016566173
- 3008191251
- 3007311878
- 9613910
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KQX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011827 | ORTELIUS 800 | Orthoscan , Ltd. | 2001-08-28 |
| K971079 | INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE | Interlogics, Inc. | 1997-07-09 |
| K962377 | 3D-SPINE | Skill Technologies, Inc. | 1996-09-03 |
| K961212 | SPINAL TOUCH | Fasstech | 1996-06-12 |
| K954647 | INCLINOMETER | J-Tech, Inc. | 1995-10-30 |
| K943929 | DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) | Greenleaf Medical Systems, Inc. | 1995-05-15 |
| K945630 | LARGE MUSCLE STRENGTH GAUGE | J-Tech, Inc. | 1995-05-10 |
| K943898 | SAUNDERS ELECTRONIC INCLINOMETER | The Saunders Group | 1994-11-28 |
| K940812 | INSIGHT ELECTRONIC ALIGNMENT INDICATOR | Andronic Devices, Ltd. | 1994-11-21 |
| K925225 | THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK | Baltimore Therapeutic Equipment Co. | 1994-06-27 |
| K933063 | ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA | Isotechnologies, Inc. | 1994-01-27 |
| K924416 | BOOST, MICE, GAMESYS. | Penny and Giles Biometrics , Ltd. | 1993-06-15 |
| K922550 | ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM) | Verimed Holdings, Inc. | 1992-12-10 |
| K920256 | SPINE MOTION ANALYZER WITH EMG | Orthopedic Systems, Inc. | 1992-08-10 |
| K920690 | NOROTRACK 360 INCLINOMETER | Noromed, Inc. | 1992-05-20 |
Legacy Summary#
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FDA Review#
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