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FDA 510(k), K160992, HPM-6000
FDA 510(k), K160992, HPM-6000
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510(K) Number: K160992
Device Name: HPM-6000
Manufacturer: BTL INDUSTRIES, INC.
Device Classification Name: stimulator, muscle, powered
Regulation Number: 890.5850
Classification Product Code: IPF
Date Received: 04/08/2016
Decision Date: 10/21/2016
Regulation Medical Specialty: Physical Medicine
Device Name: HPM-6000
Manufacturer: BTL INDUSTRIES, INC.
Device Classification Name: stimulator, muscle, powered
Regulation Number: 890.5850
Classification Product Code: IPF
Date Received: 04/08/2016
Decision Date: 10/21/2016
Regulation Medical Specialty: Physical Medicine
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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