ANKLE FOOT ORTHOSIS
FDA 510(k) clearance K821639 · decided 1982-06-11
Clearance details
- K-number
- K821639
- Device name
- ANKLE FOOT ORTHOSIS
- Applicant
- Fred Sammons, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-03
- Decision date
- 1982-06-11
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- ITW
- Device class
- 1
- Regulation number
- 890.3475
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fred Sammons
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.