STONEHEART ROLLER AID
FDA 510(k) clearance K925247 · decided 1993-02-12
Clearance details
- K-number
- K925247
- Device name
- STONEHEART ROLLER AID
- Applicant
- Stoneheart, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-10-16
- Decision date
- 1993-02-12
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- INM
- Device class
- 1
- Regulation number
- 890.3100
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Cheney, WA, 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 |
|---|---|---|
| NISSIN PEDIATRIC SERIES WHEELCHAIR (K063521) | Nissin Medical, Inc. | 2007-02-05 |
| STRYKER 5050 STRECHAIR (K941738) | Stryker Medical | 1994-05-06 |
| CAREMOR CLINER (K941569) | Winco, Inc. | 1994-04-26 |
| RECLINING GERI CHAIRS W/CASTERS & LAP TRAY (K933000) | Winco, Inc. | 1993-09-30 |
| BENCHES (K926028) | Theradapt Products, Inc. | 1993-03-24 |
| CHAIRS (K926025) | Theradapt Products, Inc. | 1993-03-22 |
| ELD-ARONDAK CHAIR (K926054) | Al'S Woodcraft, Inc. | 1993-03-22 |
| ELD-ARONDAK CHAIR (K926053) | Alert Care, Inc. | 1993-03-22 |
| KAYE SCOOT-ABOUT, MODEL SB1 (K924848) | Kaye Products, Inc. | 1993-02-12 |
| SHOWER CHAIRS (K922045) | Medical Device Inspection Co., Inc. | 1992-05-26 |
| DOLOMITE ROLLATOR (K921917) | Seamark Technologies | 1992-05-26 |
| AMBULATOR (K921752) | The Anthros Medical Group | 1992-05-04 |
Recalls involving this device
No recalls on record reference this clearance.