PERI-COMFORT(TM) SEATING CUSHION
FDA 510(k) clearance K932396 · decided 1993-09-30
Clearance details
- K-number
- K932396
- Device name
- PERI-COMFORT(TM) SEATING CUSHION
- Applicant
- Chi'Am Intl.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-18
- Decision date
- 1993-09-30
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- LRL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Circle Pines, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HEMAWAY SEAT (K072690) | Hemaway, LLC | 2007-12-07 |
| HEMOREST(TM) (K864470) | Health Aid Products | 1987-06-23 |
Recalls involving this device
No recalls on record reference this clearance.