Heterodynamic
FDA 510(k) K821157 · Birtcher Corp.
510(k) numberK821157
Submission
- Device name
- Heterodynamic
- Applicant
- Birtcher Corp.
Mchenry, IL, US - Received
- April 22, 1982
- Decision date
- June 23, 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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| K240234 | BTL-899MSIPF · Traditional | BTL Industries, Inc. | 08/17/2024SE |
| K233098 | MYOTouch Muscle StimulatorIPF · Traditional | Sunmed, LLC | 08/02/2024SE |
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| K850668 | Electrosurgical Unit 774GEI · Traditional | 05/20/1985SE |
| K844101 | Cardio-Nec Model 365DPS · Traditional | 04/09/1985SE |
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Questions and answers
When was Heterodynamic cleared by the FDA?
Heterodynamic (K821157) received a 510(k) decision of Substantially Equivalent on June 23, 1982, 62 days after the submission was received.
What is the product code of K821157?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.