Product code IOD
- Device name
- Components, Exercise
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5350
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K831544 | DELUXE TRACTION EXERCISE GLOVE BK5035 | Fred Sammons, Inc. | 1983-06-24 |
| K823648 | SURGICAL TUBING | Fred Sammons, Inc. | 1983-01-21 |
| K823822 | ANKLE WEIGHTS | Danek Medical, Inc. | 1983-01-14 |
| K823600 | SOLID WOOD CONE | Fred Sammons, Inc. | 1982-12-22 |
| K813632 | COLOR CODED WEIGHT CUFFS | Fred Sammons, Inc. | 1982-01-19 |
| K812319 | THERAPY BENCH | Kaye Products, Inc. | 1981-08-31 |
| K790587 | CANVAS WEDGE | Maddak, Inc. | 1979-04-03 |
| K772414 | SANDBAGS, VARIOUS WEIGHTS | Fred Sammons, Inc. | 1978-02-01 |
| K771030 | FLEXION MITTENS | Stat Medical Corp. | 1977-06-27 |
| K761118 | HAND SCREW CLAMP | Fred Sammons, Inc. | 1976-12-02 |
| K761119 | SHEET METAL CLAMP | Fred Sammons, Inc. | 1976-12-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810113576367 | Vive | VIVE HEALTH LLC | 2024-08-20 |
| 00810113574356 | Vive | VIVE HEALTH LLC | 2024-07-17 |
| 00057475571184 | BIOS Living | Thermor Ltd | 2023-09-18 |
| 00810113573403 | Vive | VIVE HEALTH LLC | 2023-08-23 |
| 00810041982353 | VIVE | VIVE HEALTH LLC | 2023-06-30 |
| 00810041982308 | Vive | VIVE HEALTH LLC | 2022-02-01 |
| 00612479241992 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479242173 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479242159 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479242135 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479242111 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479242098 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479242074 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479242050 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479242036 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479242012 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241978 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241954 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241930 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241916 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241893 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241879 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241855 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241831 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241817 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241794 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241770 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241756 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241732 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241718 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-04-25 |