Pulsarii, High Volt. Galvanic Musc. Stim
FDA 510(k) K810064 · Bomed Medical Mfr., Ltd.
510(k) numberK810064
Submission
- Device name
- Pulsarii, High Volt. Galvanic Musc. Stim
- Applicant
- Bomed Medical Mfr., Ltd.
Mchenry, IL, US - Received
- January 13, 1981
- Decision date
- January 26, 1981
- 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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| K831422 | BioflowDSB · Traditional | 09/12/1983SE |
| K831421 | Bomed BioconDSB · Traditional | 09/12/1983SE |
| K830792 | Pulsette 110 Transcutaneous Elec-NerveGZJ · Traditional | 03/29/1983SE |
| K813020 | Bomed-NccomDXG · Traditional | 12/14/1981SE |
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Questions and answers
When was Pulsarii, High Volt. Galvanic Musc. Stim cleared by the FDA?
Pulsarii, High Volt. Galvanic Musc. Stim (K810064) received a 510(k) decision of Substantially Equivalent on January 26, 1981, 13 days after the submission was received.
What is the product code of K810064?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.