CHAL-2500
FDA 510(k) K946186 · Hogan & Hartson
510(k) numberK946186
Submission
- Device name
- CHAL-2500
- Applicant
- Hogan & Hartson
Washington, D.C., DC, US - Received
- December 20, 1994
- Decision date
- August 14, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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 |
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| K973849 | Bioabsorbable Bankart TackMAI · Traditional | 01/06/1998SE |
| K973162 | Dual Radiation Targeting System DRTS DrapeIWE · Traditional | 11/20/1997SE |
| K950169 | Ribosomal P Eia Test SystemMQA · Traditional | 05/23/1996SE |
| K942389 | Trocars, Trocar Sleeves and Reduction SleevesHET · Traditional | 02/16/1996SE |
| K946217 | Cardiolipin M Eia Test SystemMID · Traditional | 01/24/1996SE |
| K946216 | Cardiolipin a Eia Test SystemMID · Traditional | 01/24/1996SE |
| K946215 | Cardiolipin G Eia Test SystemMID · Traditional | 01/24/1996SE |
| K941566 | CompuspeakLLZ · Traditional | 06/30/1995SE |
| K950110 | Mardx Mitochondria Eia Test SystemLJM · Traditional | 05/15/1995SE |
Questions and answers
When was CHAL-2500 cleared by the FDA?
CHAL-2500 (K946186) received a 510(k) decision of Substantially Equivalent for Some Indications on August 14, 1995, 237 days after the submission was received.
What is the product code of K946186?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.