FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇹 Austria
myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
K Number: K253256
·
Decision Apr 22, 2026
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
3
Review Days
205
Basic Information
- Device Name
- myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
- K Number
- K253256
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Otto Bock Healthcare Products GmbH
- Date Received
- September 29, 2025
- Decision Date
- April 22, 2026
- Product Code
- GXY
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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