510(k) K801250
- Device
- HYDRA TRED DC
- Applicant
- MEDICHANICS, INC.
- 510(k) number
- K801250
- Product code
- IOG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-06-17
- Date received
- 1980-05-28
- Regulation
- 890.5370
- Classification name
- Treadmill, Mechanical
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010603857
- 3014498763
- 3015142701
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IOG #
Legacy Summary#
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FDA Review#
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