Product code ITJ
- Device name
- Walker, Mechanical
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3825
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K833869 | CHILD'S WALKER | Kaye Products, Inc. | 1983-11-29 |
| K833195 | UMBRELLA WALKER | Convaid Products, Inc. | 1983-10-27 |
| K830784 | WALK N ROLL | Meta-Morris | 1983-05-25 |
| K830848 | RESI-WALKER | Lic-Orthion | 1983-04-05 |
| K823105 | RESI-WALKER | Orthion Corp. | 1982-11-05 |
| K821404 | LIGHT WEIGHT ALUMINUM WALKER | Manuco Manufacturing Co., Inc. | 1982-05-21 |
| K820711 | WALK-A-CYCLE | Walk-A-Cycle Division | 1982-04-08 |
| K811485 | WALKER/CRUTCH BAG | Fred Sammons, Inc. | 1981-06-16 |
| K792064 | DELTA ROLLING SELF-LICKING WALKER | Staricat, Inc. | 1979-10-30 |
| K790529 | WALKING AID | Maddak, Inc. | 1979-04-03 |
| K772049 | WALKING AID | Guardian Products Co., Inc. | 1977-11-11 |
| K770417 | ANIMATOR | Kdk Medical Products | 1977-04-15 |
| K770608 | WALKING AID | Will Ross Co. | 1977-04-08 |
| K770166 | MANOY WALKING AID | Maddak, Inc. | 1977-01-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 14895262504730 | HOMLAND | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 14895262504716 | HOMLAND | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 14895262504709 | HOMLAND | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 14895262504693 | HOMLAND | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 14895262504280 | SOUNDFUSE | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 14895262504273 | SOUNDFUSE | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 14895262504266 | SOUNDFUSE | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
| 14895262504259 | SOUNDFUSE | HongKong Pishon Medical Equipment Co., Limited | 2026-04-22 |
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