SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS
FDA 510(k) clearance K062873 · decided 2007-03-20
Clearance details
- K-number
- K062873
- Device name
- SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS
- Applicant
- E.C.I. USA Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-09-25
- Decision date
- 2007-03-20
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- DWL
- Device class
- 2
- Regulation number
- 880.5780
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Saint Louis, MO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch E.C.I. USA Corporation
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.