Musclemax Plus Electrical Muscle Stimulator
FDA 510(k) K962462 · Smith and Nephew Donjoy, Inc.
510(k) numberK962462
Submission
- Device name
- Musclemax Plus Electrical Muscle Stimulator
- Applicant
- Smith and Nephew Donjoy, Inc.
Carsbad, CA, US - Received
- June 25, 1996
- Decision date
- September 23, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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More from Sunmed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K970051 | Musclesense II Clinical Electromyography DeviceHCC · Traditional | 07/10/1997SE |
| K963492 | Protective RestraintFMQ · Traditional | 11/12/1996SE |
| K963490 | Protective Restraint - BeltsFMQ · Traditional | 11/12/1996SE |
| K963489 | Wheel Chair AccessoryFMQ · Traditional | 11/12/1996SE |
| K955057 | Model 1100 Cold Therapy DeviceILO · Traditional | 03/08/1996SN |
| K951350 | Musclesense Electromyography DeviceHCC · Traditional | 06/23/1995SE |
| K945687 | Rounded Cannulated Inside-Out (Rci) Acl ScrewHWC · Traditional | 06/22/1995SN |
| K946313 | Tibial Routers, Femoral Routers and Tube Graft SizerHRX · Traditional | 03/17/1995SE |
| K945236 | Aims Cannulated Acl Screw (7MM Diameter)HWC · Traditional | 02/03/1995SE |
| K932592 | Brace NeutralizerGZJ · Traditional | 03/18/1994SE |
Questions and answers
When was Musclemax Plus Electrical Muscle Stimulator cleared by the FDA?
Musclemax Plus Electrical Muscle Stimulator (K962462) received a 510(k) decision of Substantially Equivalent on September 23, 1996, 90 days after the submission was received.
What is the product code of K962462?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.