510(k) K800716
- Device
- ORTHOTIC LEG GAIT CORRECTOR DEVICE
- Applicant
- IPOS LUNEBURG
- 510(k) number
- K800716
- Product code
- ITO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-05-02
- Date received
- 1980-03-31
- Regulation
- 890.3410
- Classification name
- Twister, Brace Setting
- 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#
- 2950684
- 9613183
- 1824252
- 3003855936
- 8040278
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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