Challenge 5000 Powered Muscle Stimulator
FDA 510(k) K901768 · Maximum Performance Technologies, Mpts, Inc.
510(k) numberK901768
Submission
- Device name
- Challenge 5000 Powered Muscle Stimulator
- Applicant
- Maximum Performance Technologies, Mpts, Inc.
Washington, D.C., DC, US - Received
- April 18, 1990
- Decision date
- July 3, 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
Other 510(k)s with product code IPF
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|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M)IPF · Traditional | Weero Co., Ltd. | 06/08/2026SE |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF · Traditional | Mohammadali Nezakati | 06/02/2026SE |
| K260142 | StimelMD (SSMD) systemIPF · Special | Motion Informatics ltd. | 05/27/2026SE |
| K251083 | Compact IIIPF · Traditional | Enraf-Nonius, B.V. | 09/12/2025SE |
| K241433 | EVE Synergy (EVE-20M)IPF · Traditional | Weero Co., Ltd. | 06/04/2025SE |
| K241488 | TrainFES AdvanceIPF · Traditional | Trainfes | 02/05/2025SE |
| K240348 | Quantum Mitohormesis (QMT) (M2101)IPF · Abbreviated | Quantumtx Pte. , Ltd. | 12/19/2024SE |
| 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 |
| K903149 | Chanllenge 1010 Patient Key Program StationIPF · Traditional | 11/05/1990SE |
| 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 |
| K901326 | Challenge 20 Powered Muscle StimulatorIPF · Traditional | 05/29/1990SE |
Questions and answers
When was Challenge 5000 Powered Muscle Stimulator cleared by the FDA?
Challenge 5000 Powered Muscle Stimulator (K901768) received a 510(k) decision of Substantially Equivalent on July 3, 1990, 76 days after the submission was received.
What is the product code of K901768?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.