Medcolator Model HVX
FDA 510(k) K844580 · Medco Products, Co., Inc.
510(k) numberK844580
Submission
- Device name
- Medcolator Model HVX
- Applicant
- Medco Products, Co., Inc.
Tinton Falls, NJ, US - Received
- November 23, 1984
- Decision date
- February 25, 1985
- 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 |
|---|---|---|
| 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 |
| K842712 | Medcolator Model GXIPF · Traditional | 09/19/1984SE |
| K822829 | Rotary Vascular KnifeDWS · Traditional | 11/17/1982SE |
Questions and answers
When was Medcolator Model HVX cleared by the FDA?
Medcolator Model HVX (K844580) received a 510(k) decision of Substantially Equivalent on February 25, 1985, 94 days after the submission was received.
What is the product code of K844580?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.