Chanllenge 1010 Patient Key Program Station
FDA 510(k) K903149 · Maximum Performance Technologies, Mpts, Inc.
510(k) numberK903149
Submission
- Device name
- Chanllenge 1010 Patient Key Program Station
- Applicant
- Maximum Performance Technologies, Mpts, Inc.
Washington, DC, US - Received
- July 18, 1990
- Decision date
- November 5, 1990
- Decision
- Substantially Equivalent (SESE)
- 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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| K241488 | TrainFES AdvanceIPF · Traditional | Trainfes | 02/05/2025SE |
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| K240992 | eMVFit (MVF-10M)IPF · Traditional | Weero Co., Ltd. | 10/10/2024SE |
| K240234 | BTL-899MSIPF · Traditional | BTL Industries, Inc. | 08/17/2024SE |
| K233098 | MYOTouch Muscle StimulatorIPF · Traditional | Sunmed, LLC | 08/02/2024SE |
More from Sunmed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K903148 | Challenge 3000 Neurological BoosterIPF · Traditional | 12/10/1991SE |
| K904360 | Challenge 4010 One Channel Wide Pulse StimulatorIPF · Traditional | 10/15/1991SE |
| K902514 | Challenge 5010 Powered Muscle StimulatorIPF · Traditional | 08/31/1990SE |
| K902513 | Challenge 6010 Powered Muscle StimulatorIPF · Traditional | 08/31/1990SE |
| K902512 | Challenge 8000 Powered Muscle StimulatorIPF · Traditional | 08/31/1990SE |
| K902511 | Challenge 7010 Powered Muscle StimulatorIPF · Traditional | 08/31/1990SE |
| K901770 | Challenge 7000 Powered Muscle StimulatorIPF · Traditional | 07/03/1990SE |
| K901769 | Challenge 6000 Powered Muscle StimulatorIPF · Traditional | 07/03/1990SE |
| K901768 | Challenge 5000 Powered Muscle StimulatorIPF · Traditional | 07/03/1990SE |
| K901326 | Challenge 20 Powered Muscle StimulatorIPF · Traditional | 05/29/1990SE |
Questions and answers
When was Chanllenge 1010 Patient Key Program Station cleared by the FDA?
Chanllenge 1010 Patient Key Program Station (K903149) received a 510(k) decision of Substantially Equivalent on November 5, 1990, 110 days after the submission was received.
What is the product code of K903149?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.