| Primary Device ID | 00815027012420 |
| NIH Device Record Key | e9968d83-b06b-409a-843a-9f8dc8828562 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DALTON KNEE WALKER |
| Version Model Number | AKN411AR |
| Company DUNS | 874709348 |
| Company Name | DALTON MEDICAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815027012420 [Primary] |
| ITJ | Walker, Mechanical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-25 |
| Device Publish Date | 2025-07-17 |
| 00815027012420 - DALTON KNEE WALKER | 2025-07-25KNEE WALKER LIMIT 300 LBS ONE SEAT W/PARKING LOCKS AND BASKET |
| 00815027012420 - DALTON KNEE WALKER | 2025-07-25 KNEE WALKER LIMIT 300 LBS ONE SEAT W/PARKING LOCKS AND BASKET |
| 00815027012710 - DALTON ROLLATOR | 2025-07-25 ROLLATOR ALUM W/10" WHEELS AND BRAKE RED |
| 00815027012727 - DALTON ROLLATOR | 2025-07-25 ROLLATOR ALUM W/10" WHEELS AND BRAKE BLUE |
| 00815027010303 - DALTON WET WIPE | 2025-05-23 WET WIPE, UNSCENT, 7.9"X12", 48/PK |
| 00815027012598 - DALTON UNDERPAD | 2025-05-23 UNDERPAD 23X36, 120/CS, BLUE, 40G |
| 00815027012604 - DALTON UNDERPAD | 2025-05-23 UNDERPAD 23X36, 120/CS, GREEN, 50G |
| 00815027012611 - DALTON UNDERPAD | 2025-05-23 UNDERPAD 30X36, 100/CS, PINK 94G |
| 00815027012642 - DALTON TILE-IN-SPACE MANUAL WHEELCHAIR | 2025-01-07 WHEELCHAIR, MANUAL, 16" W/LEGREST, LATERAL SUPPORT, TILE-IN-SPACE, ADJUSTABLE ARM |