ITJ — Walker, Mechanical Class I
FDA product code ITJ covers "Walker, Mechanical", a Class I medical device regulated under 21 CFR 890.3825. Submissions are reviewed by the Physical Medicine panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ITJ
- Device Class
- Class I
- Regulation Number
- 890.3825
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K833869 | kaye products | CHILD'S WALKER | November 29, 1983 |
| K833195 | convaid products | UMBRELLA WALKER | October 27, 1983 |
| K830784 | meta-morris | WALK N ROLL | May 25, 1983 |
| K830848 | lic-orthion | RESI-WALKER | April 5, 1983 |
| K823105 | orthion | RESI-WALKER | November 5, 1982 |
| K821404 | manuco manufacturing co | LIGHT WEIGHT ALUMINUM WALKER | May 21, 1982 |
| K820711 | walk-a-cycle division | WALK-A-CYCLE | April 8, 1982 |
| K811485 | fred sammons | WALKER/CRUTCH BAG | June 16, 1981 |
| K792064 | staricat | DELTA ROLLING SELF-LICKING WALKER | October 30, 1979 |
| K790529 | maddak | WALKING AID | April 3, 1979 |
| K772049 | guardian products co | WALKING AID | November 11, 1977 |
| K770417 | kdk medical products | ANIMATOR | April 15, 1977 |
| K770608 | will ross | WALKING AID | April 8, 1977 |
| K770166 | maddak | MANOY WALKING AID | January 28, 1977 |