Medcolator Model GX
FDA 510(k) K842712 · Medco Products, Co., Inc.
510(k) numberK842712
Submission
- Device name
- Medcolator Model GX
- Applicant
- Medco Products, Co., Inc.
Mchenry, IL, US - Received
- July 12, 1984
- Decision date
- September 19, 1984
- 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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| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF · Traditional | Mohammadali Nezakati | 06/02/2026SE |
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| 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 |
|---|---|---|
| K932466 | Medchem Surgical Delivery SystemGCJ · Traditional | 08/09/1993SE |
| K913172 | Endoscopic Delivery SystemGCJ · Traditional | 09/06/1991SE |
| K860099 | Medco-Sonic NQ-2000IMI · Traditional | 04/09/1986SE |
| K852015 | Jyrochair, Model Sk-HITI · Traditional | 07/19/1985SE |
| K851659 | Skull Mounted Stereotactic Surgical DeviceHAW · Traditional | 07/01/1985SE |
| K844580 | Medcolator Model HVXIPF · Traditional | 02/25/1985SE |
| K822829 | Rotary Vascular KnifeDWS · Traditional | 11/17/1982SE |
Questions and answers
When was Medcolator Model GX cleared by the FDA?
Medcolator Model GX (K842712) received a 510(k) decision of Substantially Equivalent on September 19, 1984, 69 days after the submission was received.
What is the product code of K842712?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.