FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MyCRO Band
K Number: K213587
·
Decision Jun 9, 2022
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
42
Applicant Total
17
Review Days
209
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MyCRO Band
- K Number
- K213587
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5970
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Otto Bock Healthcare LP
- Date Received
- November 12, 2021
- Decision Date
- June 9, 2022
- Product Code
- MVA
- 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 |
|---|---|---|---|
| MVA | Orthosis, Cranial | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MVA), ordered by most recent decision date.
Talee, Talee PostOp
FDA 510(k)
FDA Class 2
·Neurology
Talee, Talee PostOp
FDA 510(k)
FDA Class 2
·Neurology
STARband 3D
FDA 510(k)
FDA Class 2
·Neurology
Talee, Talee PostOP
FDA 510(k)
FDA Class 2
·Neurology
Hanger Cranial Band 3D
FDA 510(k)
FDA Class 2
·Neurology
SnugKap
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Otto Bock Healthcare LP
| K Number | Device Name | ||
|---|---|---|---|
| K201426 | MyCRO Band | Mar 26, 2021 | Substantially Equivalent |
| K113164 | DISCOVERY TMAX MANUAL WHEELCHAIR | Mar 11, 2013 | Substantially Equivalent |
| K111278 | Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE | Sep 16, 2011 | Substantially Equivalent |
| K111045 | CENTRO FAMILY OF MANUAL WHEELCHAIRS | Jul 15, 2011 | Substantially Equivalent |
| K101524 | C2000 POWERED WHEELCHAIR | Sep 29, 2010 | Substantially Equivalent |
| K082314 | BRAVORACER PEDIATRIC MANUAL WHEELCHAIR | Oct 28, 2008 | Substantially Equivalent |
| K073512 | START JUNIOR | Jan 14, 2008 | Substantially Equivalent |
| K070318 | SKIPPI POWERED WHEELCHAIR FOR CHILDREN | May 11, 2007 | Substantially Equivalent |
| K052771 | SENSOR WALK | May 3, 2006 | Substantially Equivalent |
| K052706 | A-200 POWERED WHEELCHAIR | Dec 27, 2005 | Substantially Equivalent |