CRAWLER
FDA 510(k) clearance K841695 · decided 1984-05-10
Clearance details
- K-number
- K841695
- Device name
- CRAWLER
- Applicant
- Maddak, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-23
- Decision date
- 1984-05-10
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- KNL
- Device class
- 1
- Regulation number
- 890.5370
- 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 |
|---|---|---|
| SCOOTER BOARD (K811489) | Fred Sammons, Inc. | 1981-06-12 |
| THERAPY GYROSCOPE (K790528) | Maddak, Inc. | 1979-04-03 |
| BOARD, SCOOTER (K781198) | Fred Sammons, Inc. | 1978-07-31 |
| THERAPY SCOOTER (K780296) | Convaid Product Development | 1978-02-24 |
Recalls involving this device
No recalls on record reference this clearance.