M-Wave
Zynex Medical, Inc. · Physical Medicine
Open FDA's page for this record- Third party flag
- N
- City
- Englewood
- Advisory committee description
- Physical Medicine
- Address 1
- 9655 Maroon Cir.
- Statement or summary
- Statement
- Product code
- IPF
- Zip code
- 80112
- Applicant
- Zynex Medical, Inc.
- Decision date
- 2024-01-26
- Decision code
- SESE
- Country code
- US
- Device name
- M-Wave
- Advisory committee
- PM
- Contact
- Thomas Sandgaard
- K number
- K233485
- State
- CO
- Date received
- 2023-10-27
- Review advisory committee
- PM
- Postal code
- 80112
- Decision description
- Substantially Equivalent
- Clearance type
- Abbreviated
- Harmonized identifiers (openFDA)
- Device name
- Stimulator, Muscle, Powered
- Medical specialty description
- Physical Medicine
- Regulation number
- 890.5850
- Device class
- 2
- Registration number
- 3004081884, 3010097863, 3023613474, 9680487, 3005170249, 3043153468, 2954348, 9710616, 3025367760, 3012651177, 1721293, 1061158, 3015452693, 3038295706, 8021774, 3006850006, 3004183512, 3013445676, 3010078417, 3025235024, 1054713, 3012981024, 3035374386, 3036471706, 3009437400, 3015529344, 3010385841, 3009411292, 3001676837, 9616086, 3043657394, 9611612, 3011767724, 9710567, 3005569927, 3046040683, 3016508547, 3006551156, 2026803, 3004049909 +134 more
- FEI number
- 3004081884, 3926, 3010097863, 3006076154, 3023613474, 3005170249, 3043153468, 3002808188, 3003256355, 3025367760, 3012651177, 1000119345, 3002807847, 3015452693, 3038295706, 3006850006, 3004183512, 3013445676, 3010078417, 3003267895, 3025235024, 3012981024, 3035374386, 3036471706, 3009437400, 3015529344, 3002893067, 3010385841, 3009411292, 3001676837, 3043657394, 1000122747, 3011767724, 3004668996, 3005569927, 3046040683, 3016508547, 3006551156, 2026803, 3004049909 +134 more