Compex 2
FDA 510(k) K940301 · Biodex Medical Systems, Inc.
510(k) numberK940301
Submission
- Device name
- Compex 2
- Applicant
- Biodex Medical Systems, Inc.
Shirley, NY, US - Received
- January 24, 1994
- Decision date
- December 28, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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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| K240234 | BTL-899MSIPF · Traditional | BTL Industries, Inc. | 08/17/2024SE |
| K233098 | MYOTouch Muscle StimulatorIPF · Traditional | Sunmed, LLC | 08/02/2024SE |
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| K942694 | Stability System (110V) Model 945-300; Stability System (220V) Model #945-302KHX · Traditional | 03/10/1995SE |
| K935520 | Upper Body Cycles (110 VOLT)/(220 Volt)BXB · Traditional | 09/16/1994SE |
| K935216 | Semi-Recumbent CyclesBXB · Traditional | 09/16/1994SE |
| K935061 | Lower Body CyclesBXB · Traditional | 09/16/1994SE |
Questions and answers
When was Compex 2 cleared by the FDA?
Compex 2 (K940301) received a 510(k) decision of Substantially Equivalent for Some Indications on December 28, 1994, 338 days after the submission was received.
What is the product code of K940301?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.