Splint, Temporary Training
A temporary training splint is a provisional immobilization device used in rehabilitation settings to support and position a limb during early stages of recovery or prosthetic training. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IQM, regulated under 21 CFR 890.3025, within the Physical Medicine medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- IQM
- Device Class
- FDA class 1
- Regulation Number
- 890.3025
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K771287 | FINGEO EXTENSION SPLINTS | Jul 21, 1977 | Substantially Equivalent | Fred Sammons, Inc. |
| K770891 | SPLINH, FOREARM | May 26, 1977 | Substantially Equivalent | Orthopedic Systems, Inc. |
| K770890 | SPLINT, COCKUP | May 26, 1977 | Substantially Equivalent | Orthopedic Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 43 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 43 registration numbers. Click on an entry to view related FDA registrations.