510(k) K012492
- Device
- KADANCE 2000
- Applicant
- KADA RESEARCH, INC.
- 510(k) number
- K012492
- Product code
- LBB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-02
- Date received
- 2001-08-03
- Regulation
- 888.1240
- Classification name
- Dynamometer, Ac-powered
- Medical specialty
- Orthopedic
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HARVEY KNAUSS
- Address
- 11874 S. Evelyn Cir. Houston TX US 77071 77071
FDA Registration Numbers#
- 3043587013
- 3003074886
- 3043149893
- 3008717264
- 3015316271
- 3021172399
- 3016711710
- 3036833417
- 3012302888
- 8040255
- 3025591939
- 3042749557
- 3016566173
- 3009787507
- 3019492433
- 3016076693
Source Documents#
Other 510(k) Records For Product Code LBB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162412 | Hoggan Scientific® microFET2™ | Hoggan Scientific, LLC | 2017-03-09 |
| K073154 | FACTS HAND AND PINCH GRIP COMBO | Global Services Group, LLC | 2008-02-14 |
| K052309 | DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 | Saehan Corp. | 2005-09-27 |
| K042889 | DYNAMOMETER - MODEL FCE AND MODEL MSC | Ametek | 2004-11-16 |
| K981730 | DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 | Nk Biotechnical Corp. | 1998-07-17 |
| K980363 | ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) | Orofacial Dynamics | 1998-04-16 |
| K964933 | MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) | Mekanika, Inc. | 1997-02-03 |
| K964685 | DYNAMOMETER | John Chatillon & Sons, Inc. | 1997-01-27 |
| K935757 | GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM | Greenleaf Medical Systems, Inc. | 1994-04-15 |
| K931321 | CSD 200/300/400/500 DYNAMOMETER | John Chatillon & Sons, Inc. | 1994-02-15 |
| K923965 | NK GRASP SENSOR, MODEL GA002 | Nk Biotechnical Engineering Co. | 1993-05-12 |
| K923964 | NK GRASP SENSOR, MODEL GA001 | Nk Biotechnical Engineering Co. | 1993-05-12 |
| K923963 | NK DIGI-GRIP SENSOR, MODEL DGR001 | Nk Biotechnical Engineering Co. | 1993-03-31 |
| K923262 | DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETER | John Chatillon & Sons, Inc. | 1992-10-27 |
| K922029 | REMUSK MP | Equipement Biomedical Specialise, Inc. | 1992-10-06 |
Legacy Summary#
summary
FDA Review#
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