Clinical Handmaster System or CHMS
FDA 510(k) K914436 · Exos Medical Products
510(k) numberK914436
Submission
- Device name
- Clinical Handmaster System or CHMS
- Applicant
- Exos Medical Products
Burlington, MA, US - Received
- October 4, 1991
- Decision date
- January 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LBB – Dynamometer, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.1240
- Specialty
- Orthopedic
Other 510(k)s with product code LBB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162412 | Hoggan Scientific® microFET2LBB · Traditional | Hoggan Scientific, LLC | 03/09/2017SE |
| K073154 | Facts Hand and Pinch Grip ComboLBB · Traditional | Global Services Group, LLC | 02/14/2008SE |
| K052309 | Digital Hand Dynamometer, Model SH5003; Digital Pinch Gauge, Model SH5006LBB · Traditional | Saehan Corp. | 09/27/2005SE |
| K042889 | Dynamometer - Model Fce and Model MSCLBB · Traditional | Ametek | 11/16/2004SE |
| K012492 | Kadance 2000LBB · Traditional | Kada Research, Inc. | 11/02/2001SE |
| K981730 | Digit-Grip with LCD, Model Number DGR 002LBB · Traditional | Nk Biotechnical Corp. | 07/17/1998SE |
| K980363 | Oro-Facial Myographic Measurement Instrument (Ommi)LBB · Traditional | Orofacial Dynamics | 04/16/1998SE |
| K964933 | Mekanika's Spinal Stiffness Gauge (SSG)LBB · Traditional | Mekanika, Inc. | 02/03/1997SE |
| K964685 | DynamometerLBB · Traditional | John Chatillon & Sons, Inc. | 01/27/1997SE |
| K935757 | Greenleaf Eval System/ Greenleaf SolosystemLBB · Traditional | Greenleaf Medical Systems, Inc. | 04/15/1994SE |
Questions and answers
When was Clinical Handmaster System or CHMS cleared by the FDA?
Clinical Handmaster System or CHMS (K914436) received a 510(k) decision of Substantially Equivalent on January 2, 1992, 90 days after the submission was received.
What is the product code of K914436?
The FDA product code is LBB – Dynamometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 888.1240.