Am 706 Electromyograph, Stim., Neuro., External
FDA 510(k) K881196 · Biometer Intl. A/S
510(k) numberK881196
Submission
- Device name
- Am 706 Electromyograph, Stim., Neuro., External
- Applicant
- Biometer Intl. A/S
Denmark, DK - Received
- March 21, 1988
- Decision date
- June 16, 1989
- 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 |
| 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 |
|---|---|---|
| K925159 | Tof-Guard Transmission MonitorKOI · Traditional | 09/01/1993SE |
| K914231 | Elpha 2000IPF · Traditional | 05/28/1992SE |
| K892396 | Mini Accelograph Neuromuscular Trans. MonitorBXN · Traditional | 10/03/1989SE |
| K893485 | Accelograph Neuromuscular Transmission MonitorBXN · Traditional | 07/28/1989SE |
| K890746 | Myotest DBS Nerve StimulatorBXN · Traditional | 07/14/1989SE |
| K870619 | AccelographBXN · Traditional | 03/16/1987SE |
| K860187 | Myograph 2000 - Neuro. Trans. Monitor & RecordingBXN · Traditional | 03/20/1986SE |
| K860186 | Myotest - Nerve StimulatorBXN · Traditional | 03/20/1986SE |
Questions and answers
When was Am 706 Electromyograph, Stim., Neuro., External cleared by the FDA?
Am 706 Electromyograph, Stim., Neuro., External (K881196) received a 510(k) decision of Substantially Equivalent on June 16, 1989, 452 days after the submission was received.
What is the product code of K881196?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.