510(k) K201290
- Device
- Medline DeNovo 4Pro Electrical Stimulation Device
- Applicant
- Medline Industries, Inc.
- 510(k) number
- K201290
- Product code
- IPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-09-21
- Date received
- 2020-05-14
- Regulation
- 890.5850
- Classification name
- Stimulator, Muscle, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Leontyne Banks
- Address
- Three Lakes Dr. Northfield IL US 60090 60090
FDA Registration Numbers
- 3003895865
- 3014774380
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Source Documents
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