Robin's Egg
FDA 510(k) clearance K240689 · decided 2024-09-17
Clearance details
- K-number
- K240689
- Device name
- Robin's Egg
- Applicant
- Telebrands Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-03-13
- Decision date
- 2024-09-17
- Days to decision
- 188 days
- Clearance type
- Traditional
- Product code
- OAP
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Fairfield, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Telebrands Corporation
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.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.