ARM THROUGH FOR WHEELCHAIR BK 6454-01 &
FDA 510(k) clearance K823638 · decided 1983-01-21
Clearance details
- K-number
- K823638
- Device name
- ARM THROUGH FOR WHEELCHAIR BK 6454-01 &
- Applicant
- Fred Sammons, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-06
- Decision date
- 1983-01-21
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- KNN
- Device class
- 1
- Regulation number
- 890.3920
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, 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 |
|---|---|---|
| KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat (K211919) | Kinetic Innovative Seating System, LLC | 2022-03-04 |
| DYNASTY U1-31 (GELL/CELL) (K942309) | Foley & Lardner | 1994-11-07 |
| DYNASTY GC 12550 (GELL/CELL) (K942310) | Foley & Lardner | 1994-11-07 |
| DYNASTY GC 12400 (GELL/CELL) (K942308) | Foley & Lardner | 1994-11-07 |
| DYNASTY U1-33 AGM (K942311) | Foley & Lardner | 1994-11-07 |
| ALDEN WHEELCHAIR CUSHION (K942260) | Ward and Assoc. | 1994-05-26 |
| ALDEN LINEAGE WHEELCHAIR CUSHION (K942312) | Lewis W. Ward | 1994-05-26 |
| ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION (K933051) | General Components Intl., Inc. | 1993-10-12 |
| RHOMBO MEDICAL RHOMBO-FILL (K923942) | International Medical Products, Inc. | 1993-03-24 |
| PM (K925980) | Pathfinder Intl. Corp. | 1993-03-24 |
| TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST (K923364) | Labac Systems, Inc. | 1993-03-22 |
| VALU-PLUS PAD (K925336) | Valmed, Inc. | 1993-02-12 |
Recalls involving this device
No recalls on record reference this clearance.