RESI-WALKER
FDA 510(k) clearance K830848 · decided 1983-04-05
Clearance details
- K-number
- K830848
- Device name
- RESI-WALKER
- Applicant
- Lic-Orthion
- Decision
- Substantially Equivalent
- Date received
- 1983-03-17
- Decision date
- 1983-04-05
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- ITJ
- Device class
- 1
- Regulation number
- 890.3825
- 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 |
|---|---|---|
| CHILD'S WALKER (K833869) | Kaye Products, Inc. | 1983-11-29 |
| UMBRELLA WALKER (K833195) | Convaid Products, Inc. | 1983-10-27 |
| WALK N ROLL (K830784) | Meta-Morris | 1983-05-25 |
| RESI-WALKER (K823105) | Orthion Corp. | 1982-11-05 |
| LIGHT WEIGHT ALUMINUM WALKER (K821404) | Manuco Manufacturing Co., Inc. | 1982-05-21 |
| WALK-A-CYCLE (K820711) | Walk-A-Cycle Division | 1982-04-08 |
| WALKER/CRUTCH BAG (K811485) | Fred Sammons, Inc. | 1981-06-16 |
| DELTA ROLLING SELF-LICKING WALKER (K792064) | Staricat, Inc. | 1979-10-30 |
| WALKING AID (K790529) | Maddak, Inc. | 1979-04-03 |
| WALKING AID (K772049) | Guardian Products Co., Inc. | 1977-11-11 |
| ANIMATOR (K770417) | Kdk Medical Products | 1977-04-15 |
| WALKING AID (K770608) | Will Ross Co. | 1977-04-08 |
Recalls involving this device
No recalls on record reference this clearance.