Product code ION
- Device name
- Exerciser, Non-Measuring
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5370
- 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 |
|---|---|---|---|
| K120783 | ABLE-X | Im-Able, Ltd. | 2012-06-20 |
| K885343 | STANDEX | Alt, Inc. | 1989-05-01 |
| K851065 | GRAVITY KING (DEEMED SE 87/09/18) | Unique Functional Products | 1985-06-13 |
| K840551 | MOBILIZER | Lossing Orthopedic, Inc. | 1984-03-23 |
| K833870 | KNEE WALKER | Maddak, Inc. | 1983-11-29 |
| K833249 | FITNESS | Fitness Equipment Co., Inc. | 1983-11-07 |
| K832968 | PEDAL EXERCISER | Maddak, Inc. | 1983-09-29 |
| K831543 | ADJUST. WEIGHTS-BK5171-05,10,20 BEOK | Fred Sammons, Inc. | 1983-06-24 |
| K831538 | DELUXE ADJUST-ANGLE BOARD-BK4066 | Fred Sammons, Inc. | 1983-06-08 |
| K831033 | GIREX | Lancer Assoc. | 1983-04-27 |
| K830400 | MADDATRAINER HAND EXERCISER | Maddak, Inc. | 1983-03-09 |
| K830560 | EXERCISER, PASSIVE, NON MEASURING | Kaye Products, Inc. | 1983-03-09 |
| K823236 | BACK ON TRACK INVERSION THERAPY & EXER | Lossing Orthopedic, Inc. | 1983-01-21 |
| K823623 | INFLATABLE HEAVY PLASTIC EXERCISER | Fred Sammons, Inc. | 1982-12-28 |
| K823620 | PLASTIC ELASTOMER IN CUBE FORM EXERCISE | Fred Sammons, Inc. | 1982-12-22 |
| K823619 | PLASTIC ELASTOMER ENCASED IN TERRY CLOTH | Fred Sammons, Inc. | 1982-12-22 |
| K823618 | PROGRESSIVE RESISTANCE EXERCISE CUFF | Fred Sammons, Inc. | 1982-12-22 |
| K822906 | PHYSICAL MEDICINE & REHABILITATION EQUIP | I-Rep, Inc. | 1982-10-15 |
| K821857 | BK-5305 MULTIPLE HAND GRID | Fred Sammons, Inc. | 1982-07-02 |
| K821855 | VISCO HANDEX-VARIOUS MODELS | Fred Sammons, Inc. | 1982-07-02 |
| K813633 | MODELING COMPOUND AND FOAM EXERCISER | Fred Sammons, Inc. | 1982-01-19 |
| K813099 | BACK RIE | Back Rite | 1981-11-24 |
| K812474 | BABY WALKER W/TOY CHEST | Maddak, Inc. | 1981-09-14 |
| K812351 | NON-MEASURING EXERCISERS | Fred Sammons, Inc. | 1981-09-14 |
| K810444 | NON-MEASURING EXERCISERS | Fred Sammons, Inc. | 1981-03-04 |
| K801710 | BK-5315-01 FOAM HAND EXERCISER, SMALL | Fred Sammons, Inc. | 1980-08-07 |
| K801453 | FINGER, HAND & WRIST EXERCISER | Robert W. Slack | 1980-08-04 |
| K792642 | THE VARIABLE LOAD KENETIC ENERGIZER | W.F. Pogue | 1980-01-28 |
| K800017 | COLOR CODED PUTTY SOFT, REGULAR & FIRM | Fred Sammons, Inc. | 1980-01-21 |
| K790572 | LOUNGE, TILT-A-BODY STRETCH | Innovative Products, Inc. | 1979-04-10 |
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| 08054040402029 | FRAME RUNNER | ORMESA SRL | 2025-10-15 |
| 08054040402036 | FRAME RUNNER | ORMESA SRL | 2025-10-15 |
| 07640174660353 | Armeo | HOCOMA AG | 2023-10-11 |
| 00612479242074 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241916 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241930 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241954 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241978 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241992 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479242012 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479242036 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479242050 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479241855 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479242098 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479242111 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-05-22 |
| 00612479242135 | 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 |
| 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 |
| 07640174660001 | Armeo | HOCOMA AG | 2016-08-22 |
| 07640174660193 | Armeo | HOCOMA AG | 2016-08-22 |
| 07640174660186 | Armeo | HOCOMA AG | 2016-08-22 |
| 07640174660018 | Armeo | HOCOMA AG | 2016-08-22 |