ERGOSEAT SYSTEM
FDA 510(k) clearance K954162 · decided 1995-10-30
Clearance details
- K-number
- K954162
- Device name
- ERGOSEAT SYSTEM
- Applicant
- Ergo-Air, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-09-05
- Decision date
- 1995-10-30
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- MOC
- Device class
- 2
- Regulation number
- 890.5170
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Marblehead, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ergo-Air
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.
| Record | Firm | Date |
|---|---|---|
| IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION) (K063175) | Medical Technology Systems, Inc. | 2008-03-14 |
Recalls involving this device
No recalls on record reference this clearance.