Components, Exercise
Exercise Components are individual parts or accessories used in Physical Medicine rehabilitation exercise equipment, including resistance bands, pulleys, weights, handles, and mechanical components that form part of a therapeutic exercise apparatus used for strengthening and functional rehabilitation. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IOD, regulated under 21 CFR 890.5350, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.
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Basic Information
- Product Code
- IOD
- Device Class
- FDA class 1
- Regulation Number
- 890.5350
- 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 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K831544 | DELUXE TRACTION EXERCISE GLOVE BK5035 | Jun 24, 1983 | Substantially Equivalent | Fred Sammons, Inc. |
| K823648 | SURGICAL TUBING | Jan 21, 1983 | Substantially Equivalent | Fred Sammons, Inc. |
| K823822 | ANKLE WEIGHTS | Jan 14, 1983 | Substantially Equivalent | Danek Medical, Inc. |
| K823600 | SOLID WOOD CONE | Dec 22, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K813632 | COLOR CODED WEIGHT CUFFS | Jan 19, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K812319 | THERAPY BENCH | Aug 31, 1981 | Substantially Equivalent | Kaye Products, Inc. |
| K790587 | CANVAS WEDGE | Apr 03, 1979 | Substantially Equivalent | Maddak, Inc. |
| K772414 | SANDBAGS, VARIOUS WEIGHTS | Feb 01, 1978 | Substantially Equivalent | Fred Sammons, Inc. |
| K771030 | FLEXION MITTENS | Jun 27, 1977 | Substantially Equivalent | Stat Medical Corp. |
| K761119 | SHEET METAL CLAMP | Dec 02, 1976 | Substantially Equivalent | Fred Sammons, Inc. |
| K761118 | HAND SCREW CLAMP | Dec 02, 1976 | Substantially Equivalent | Fred Sammons, Inc. |
FEI Numbers
This FDA classification entry is associated with 107 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 107 registration numbers. Click on an entry to view related FDA registrations.