ITJ · Walker, Mechanical
Physical Medicine · 21 CFR 890.3825 · Class 1
Overview
| Product Code | ITJ |
|---|---|
| Device Name | Walker, Mechanical |
| Regulation | 21 CFR 890.3825 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A mechanical walker is a four-legged device with a metal frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K833869 | CHILD'S WALKER | Kaye Products, Inc. | Nov 29, 1983 | SESE |
| K833195 | UMBRELLA WALKER | Convaid Products, Inc. | Oct 27, 1983 | SESE |
| K830784 | WALK N ROLL | Meta-Morris | May 25, 1983 | SESE |
| K830848 | RESI-WALKER | Lic-Orthion | Apr 5, 1983 | SESE |
| K823105 | RESI-WALKER | Orthion Corp. | Nov 5, 1982 | SESE |
| K821404 | LIGHT WEIGHT ALUMINUM WALKER | Manuco Manufacturing Co., Inc. | May 21, 1982 | SESE |
| K820711 | WALK-A-CYCLE | Walk-A-Cycle Division | Apr 8, 1982 | SESE |
| K811485 | WALKER/CRUTCH BAG | Fred Sammons, Inc. | Jun 16, 1981 | SESE |
| K792064 | DELTA ROLLING SELF-LICKING WALKER | Staricat, Inc. | Oct 30, 1979 | SESE |
| K790529 | WALKING AID | Maddak, Inc. | Apr 3, 1979 | SESE |
| K772049 | WALKING AID | Guardian Products Co., Inc. | Nov 11, 1977 | SESE |
| K770417 | ANIMATOR | Kdk Medical Products | Apr 15, 1977 | SESE |
| K770608 | WALKING AID | Will Ross Co. | Apr 8, 1977 | SESE |
| K770166 | MANOY WALKING AID | Maddak, Inc. | Jan 28, 1977 | SESE |
Top Applicants
- Maddak, Inc. — 2 clearances
- Convaid Products, Inc. — 1 clearance
- Fred Sammons, Inc. — 1 clearance
- Guardian Products Co., Inc. — 1 clearance
- Kaye Products, Inc. — 1 clearance
