Board, Scooter, Prone
A Prone Scooter Board is a physical medicine and rehabilitation device consisting of a low, wheeled platform on which a patient lies prone, used in physical therapy to improve upper extremity strength, vestibular function, and motor coordination. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket clearance required. The product code is KNL and it is regulated under 21 CFR 890.5370 in the Physical Medicine specialty. This device is GMP exempt.
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Basic Information
- Product Code
- KNL
- Device Class
- FDA class 1
- Regulation Number
- 890.5370
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K841695 | CRAWLER | May 10, 1984 | Substantially Equivalent | Maddak, Inc. |
| K811489 | SCOOTER BOARD | Jun 12, 1981 | Substantially Equivalent | Fred Sammons, Inc. |
| K790528 | THERAPY GYROSCOPE | Apr 03, 1979 | Substantially Equivalent | Maddak, Inc. |
| K781198 | BOARD, SCOOTER | Jul 31, 1978 | Substantially Equivalent | Fred Sammons, Inc. |
| K780296 | THERAPY SCOOTER | Feb 24, 1978 | Substantially Equivalent | Convaid Product Development |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.