Product code KQX
- Device name
- Goniometer, Ac-Powered
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.1500
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K914062 | NK DEXTERITLY BOARD, MODEL BX001 | Nk Biotechnical Engineering Co. | 1991-12-09 |
| K914060 | RANGE OF MOTION SENSOR, MODEL RM001 | Nk Biotechnical Engineering Co. | 1991-12-09 |
| K914061 | NK RANGE OF MOTION SENSOR, MODEL RM002 | Nk Biotechnical Engineering Co. | 1991-12-09 |
| K913079 | 02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360 | Lucas Sensing Systems, Inc. | 1991-09-25 |
| K897178 | DYNATRON 360 RANGE OF MOTION TESTING DEVICE | Dynatronics Corp. | 1990-04-18 |
| K894283 | COMPREHENSIVE SPINE MOTION ANALYZER | Orthopedic Systems, Inc. | 1990-01-19 |
| K893903 | KRONAMAX KUBE | Physicians Digital Co. | 1989-11-29 |
| K893455 | THE HANDSCAN SYSTEM | Digital Body Systems, Inc. | 1989-08-30 |
| K884723 | (DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM | Greenleaf Medical Systems, Inc. | 1989-02-08 |
| K884611 | THE ORTHORANGER II ELECTRONIC GONIOMETER | Medical Instruments Technology, Inc. | 1989-01-31 |
| K884003 | GONIOMETER AND BIOMEDICAL RECORDER SYSTEM | Penny & Giles Blackwood , Ltd. | 1988-12-19 |
| K873599 | EDI 320 | Cybex | 1987-10-16 |
| K862128 | DIGITAL ELECTRONIC MYO-GRAPH (MUSCLE ANALYZER) | Health Products, Inc. | 1986-07-11 |
| K852390 | CMT 1000 | Prestigeline, Inc. | 1985-07-19 |
| K832991 | HYPAL ADHESIVE TAPE | Smith & Nephew, Inc. | 1984-01-30 |
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| 00816271021060 | Ultium | Noraxon U.S.A., Inc. | 2026-03-30 |
| 00816271021053 | Ultium | Noraxon U.S.A., Inc. | 2026-03-30 |
| 00816271021046 | Ultium | Noraxon U.S.A., Inc. | 2026-03-30 |
| 00816271021039 | Ultium | Noraxon U.S.A., Inc. | 2026-03-30 |
| 00816271020872 | Ultium | Noraxon U.S.A., Inc. | 2026-03-30 |
| 00816271020865 | Ultium | Noraxon U.S.A., Inc. | 2026-03-30 |
| 00816271020803 | myoRESEARCH | Noraxon U.S.A., Inc. | 2026-03-30 |
| 00816271021091 | Ultium | Noraxon U.S.A., Inc. | 2026-03-30 |
| 00816271021107 | Ultium | Noraxon U.S.A., Inc. | 2026-03-30 |
| 00816271021114 | Ultium | Noraxon U.S.A., Inc. | 2026-03-30 |
| 00816271021121 | Ultium | Noraxon U.S.A., Inc. | 2026-03-30 |
| 00816271021138 | Ultium | Noraxon U.S.A., Inc. | 2026-03-30 |
| 00816271021145 | Ultium | Noraxon U.S.A., Inc. | 2026-03-30 |
| 00850004866184 | ActivForce 2 | ActivBody, Inc. | 2025-09-03 |
| 10853818007504 | USB C Adapter | PRECISION BIOMETRICS INC | 2024-09-03 |
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| 00850022650000 | e-vive II NMES System with Post-Op Brace; S/M, Right (ITALIAN) | Motive Health, Inc. | 2021-01-04 |
| 00850022650017 | e-vive II NMES System with Post-Op Brace; L/XL, Right (ITALIAN) | Motive Health, Inc. | 2021-01-04 |
| D792N36010 | Noromed NT-360 Inclinometer | MYOTRONICS NOROMED, INC | 2017-02-11 |
| D792N9000M0 | MES 9000 Musculoskeletal System | MYOTRONICS NOROMED, INC | 2016-09-19 |