ULE-2, MULE-2, Hand Accessory Kit
FDA 510(k) K962855 · Penny and Giles Biometrics , Ltd.
510(k) numberK962855
Submission
- Device name
- ULE-2, MULE-2, Hand Accessory Kit
- Applicant
- Penny and Giles Biometrics , Ltd.
Gwent, Wales, GB - Received
- July 22, 1996
- Decision date
- December 11, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ISD – Exerciser, Measuring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5360
- Specialty
- Physical Medicine
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| K143512 | ActiSpec Activity MonitorISD · Traditional | Sleep Modus, Inc. | 08/26/2015SE |
| K112121 | Ergoselect/GeISD · Traditional | Ergoline GmbH | 10/31/2012SE |
| K080545 | ActitrainerISD · Traditional | Actigraph, LLC | 07/24/2008SE |
| K053078 | Ergoselect 100 K/P, Ergoselect 200 K/PISD · Traditional | Ergoline GmbH | 04/27/2006SE |
| K990866 | Quinton Medtrack CR Plus TreadmillISD · Traditional | Quinton, Inc. | 04/29/1999SE |
| K990813 | RehcorISD · Traditional | Electromed Corp. | 04/12/1999SE |
| K952163 | David Back Clinic SystemISD · Traditional | Kinetic Resources, Inc. | 08/12/1996SE |
| K941033 | Physio HabISD · Traditional | Longo Industries | 02/27/1995SE |
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Questions and answers
When was ULE-2, MULE-2, Hand Accessory Kit cleared by the FDA?
ULE-2, MULE-2, Hand Accessory Kit (K962855) received a 510(k) decision of Substantially Equivalent on December 11, 1996, 142 days after the submission was received.
What is the product code of K962855?
The FDA product code is ISD – Exerciser, Measuring, a Class II (moderate risk) device regulated under 21 CFR 890.5360.