Med-Ex
FDA 510(k) K812899 · Chattanooga Group, Inc.
510(k) numberK812899
Submission
- Device name
- Med-Ex
- Applicant
- Chattanooga Group, Inc.
Walker, MI, US - Received
- October 16, 1981
- Decision date
- November 6, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LBB – Dynamometer, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.1240
- Specialty
- Orthopedic
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|---|---|---|---|
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| 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 |
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| K053223 | Triton/Tru-Trac/Tx/Triton DTS TractionITH · Traditional | 02/24/2006SE |
| K051938 | Triton/Tru-Trac/Tx Traction DevicesITH · Traditional | 09/21/2005SE |
| K040662 | Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser…ILY · Traditional | 09/08/2004SE |
| K040285 | Vectra Transportable Combo and Stim (Specialty Line Dealers); Intelect Transportable…IMG · Traditional | 04/12/2004SE |
| K031077 | Vectra Epr System and Intelect Epr SystemIMG · Traditional | 12/11/2003SE |
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Questions and answers
When was Med-Ex cleared by the FDA?
Med-Ex (K812899) received a 510(k) decision of Substantially Equivalent on November 6, 1981, 21 days after the submission was received.
What is the product code of K812899?
The FDA product code is LBB – Dynamometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 888.1240.