Walker, Mechanical
A mechanical walker is a rigid walking frame used to support body weight and improve balance and stability during ambulation for individuals with mobility impairments, typically used in rehabilitation or by elderly patients. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ITJ, regulated under 21 CFR 890.3825, within the Physical Medicine medical specialty. This device is GMP exempt.
Basic Information
- Product Code
- ITJ
- Device Class
- FDA class 1
- Regulation Number
- 890.3825
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K833869 | CHILD'S WALKER | Nov 29, 1983 | Substantially Equivalent | KAYE PRODUCTS, INC. |
| K833195 | UMBRELLA WALKER | Oct 27, 1983 | Substantially Equivalent | CONVAID PRODUCTS, INC. |
| K830784 | WALK N ROLL | May 25, 1983 | Substantially Equivalent | META-MORRIS |
| K830848 | RESI-WALKER | Apr 05, 1983 | Substantially Equivalent | LIC-ORTHION |
| K823105 | RESI-WALKER | Nov 05, 1982 | Substantially Equivalent | ORTHION CORP. |
| K821404 | LIGHT WEIGHT ALUMINUM WALKER | May 21, 1982 | Substantially Equivalent | MANUCO MANUFACTURING CO., INC. |
| K820711 | WALK-A-CYCLE | Apr 08, 1982 | Substantially Equivalent | WALK-A-CYCLE DIVISION |
| K811485 | WALKER/CRUTCH BAG | Jun 16, 1981 | Substantially Equivalent | FRED SAMMONS, INC. |
| K792064 | DELTA ROLLING SELF-LICKING WALKER | Oct 30, 1979 | Substantially Equivalent | STARICAT, INC. |
| K790529 | WALKING AID | Apr 03, 1979 | Substantially Equivalent | MADDAK, INC. |
| K772049 | WALKING AID | Nov 11, 1977 | Substantially Equivalent | GUARDIAN PRODUCTS CO., INC. |
| K770417 | ANIMATOR | Apr 15, 1977 | Substantially Equivalent | KDK MEDICAL PRODUCTS |
| K770608 | WALKING AID | Apr 08, 1977 | Substantially Equivalent | WILL ROSS CO. |
| K770166 | MANOY WALKING AID | Jan 28, 1977 | Substantially Equivalent | MADDAK, INC. |
FEI Numbers
This FDA classification entry is associated with 337 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 337 registration numbers. Click on an entry to view related FDA registrations.