Comply Neuromuscular Stimulator
FDA 510(k) K822284 · Omega-Med Intl., Inc.
510(k) numberK822284
Submission
- Device name
- Comply Neuromuscular Stimulator
- Applicant
- Omega-Med Intl., Inc.
Walker, MI, US - Received
- July 30, 1982
- Decision date
- September 17, 1982
- 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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|---|---|---|---|
| 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
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| K842603 | Omed Dispos. Instrument Guards · Traditional | 09/05/1984SE |
| K832441 | Suture-Aid BootiesKDC · Traditional | 03/05/1984SE |
| K830484 | Omed Ident-I-Band · Traditional | 03/24/1983SE |
| K821334 | Omed Fabric Instrument Covers-Radiopaq · Traditional | 05/24/1982SE |
| K813499 | Omed Disposable BulldogDXC · Traditional | 12/29/1981SE |
| K810883 | Omed Silicone Instrument CoversKDC · Traditional | 04/23/1981SE |
| K810269 | Omed Fabric Instrument CoversKDC · Traditional | 02/26/1981SE |
| K810260 | Omed Silicone LoopsKDC · Traditional | 02/26/1981SE |
Questions and answers
When was Comply Neuromuscular Stimulator cleared by the FDA?
Comply Neuromuscular Stimulator (K822284) received a 510(k) decision of Substantially Equivalent on September 17, 1982, 49 days after the submission was received.
What is the product code of K822284?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.