FDA Product Code
FDA Product Code ION — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5370
510(k) Clearances — 43 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K120783 | ABLE-X | Im-Able, Ltd. | 2012-06-20 | Traditional | PDF ↗ |
| K885343 | STANDEX | Alt, Inc. | 1989-05-01 | Traditional | PDF ↗ |
| K851065 | GRAVITY KING (DEEMED SE 87/09/18) | Unique Functional Products | 1985-06-13 | Traditional | PDF ↗ |
| K840551 | MOBILIZER | Lossing Orthopedic, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K833870 | KNEE WALKER | Maddak, Inc. | 1983-11-29 | Traditional | PDF ↗ |
| K833249 | FITNESS | Fitness Equipment Co., Inc. | 1983-11-07 | Traditional | PDF ↗ |
| K832968 | PEDAL EXERCISER | Maddak, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K831543 | ADJUST. WEIGHTS-BK5171-05,10,20 BEOK | Fred Sammons, Inc. | 1983-06-24 | Traditional | PDF ↗ |
| K831538 | DELUXE ADJUST-ANGLE BOARD-BK4066 | Fred Sammons, Inc. | 1983-06-08 | Traditional | PDF ↗ |
| K831033 | GIREX | Lancer Assoc. | 1983-04-27 | Traditional | PDF ↗ |
| K830560 | EXERCISER, PASSIVE, NON MEASURING | Kaye Products, Inc. | 1983-03-09 | Traditional | PDF ↗ |
| K830400 | MADDATRAINER HAND EXERCISER | Maddak, Inc. | 1983-03-09 | Traditional | PDF ↗ |
| K823236 | BACK ON TRACK INVERSION THERAPY & EXER | Lossing Orthopedic, Inc. | 1983-01-21 | Traditional | PDF ↗ |
| K823623 | INFLATABLE HEAVY PLASTIC EXERCISER | Fred Sammons, Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K823618 | PROGRESSIVE RESISTANCE EXERCISE CUFF | Fred Sammons, Inc. | 1982-12-22 | Traditional | PDF ↗ |
| K823619 | PLASTIC ELASTOMER ENCASED IN TERRY CLOTH | Fred Sammons, Inc. | 1982-12-22 | Traditional | PDF ↗ |
| K823620 | PLASTIC ELASTOMER IN CUBE FORM EXERCISE | Fred Sammons, Inc. | 1982-12-22 | Traditional | PDF ↗ |
| K822906 | PHYSICAL MEDICINE & REHABILITATION EQUIP | I-Rep, Inc. | 1982-10-15 | Traditional | PDF ↗ |
| K821855 | VISCO HANDEX-VARIOUS MODELS | Fred Sammons, Inc. | 1982-07-02 | Traditional | PDF ↗ |
| K821857 | BK-5305 MULTIPLE HAND GRID | Fred Sammons, Inc. | 1982-07-02 | Traditional | PDF ↗ |
| K813633 | MODELING COMPOUND AND FOAM EXERCISER | Fred Sammons, Inc. | 1982-01-19 | Traditional | PDF ↗ |
| K813099 | BACK RIE | Back Rite | 1981-11-24 | Traditional | PDF ↗ |
| K812351 | NON-MEASURING EXERCISERS | Fred Sammons, Inc. | 1981-09-14 | Traditional | PDF ↗ |
| K812474 | BABY WALKER W/TOY CHEST | Maddak, Inc. | 1981-09-14 | Traditional | PDF ↗ |
| K810444 | NON-MEASURING EXERCISERS | Fred Sammons, Inc. | 1981-03-04 | Traditional | PDF ↗ |
| K801710 | BK-5315-01 FOAM HAND EXERCISER, SMALL | Fred Sammons, Inc. | 1980-08-07 | Traditional | PDF ↗ |
| K801453 | FINGER, HAND & WRIST EXERCISER | Robert W. Slack | 1980-08-04 | Traditional | PDF ↗ |
| K792642 | THE VARIABLE LOAD KENETIC ENERGIZER | W.F. Pogue | 1980-01-28 | Traditional | PDF ↗ |
| K800017 | COLOR CODED PUTTY SOFT, REGULAR & FIRM | Fred Sammons, Inc. | 1980-01-21 | Traditional | PDF ↗ |
| K790572 | LOUNGE, TILT-A-BODY STRETCH | Innovative Products, Inc. | 1979-04-10 | Traditional | PDF ↗ |
| K790530 | PUSH BALL INCLINE | Maddak, Inc. | 1979-04-03 | Traditional | PDF ↗ |
| K790191 | VISA-GRIP | Premier Sundries, Inc. | 1979-02-08 | Traditional | PDF ↗ |
| K781350 | OBJECTS PRECISION HANDLING TEST KIT | Metro. Hospital & Health Center | 1978-10-17 | Traditional | PDF ↗ |
| K772404 | FINGER EXERCISE BOARD | Fred Sammons, Inc. | 1978-02-13 | Traditional | PDF ↗ |
| K770658 | EXERCISER, LEG, LOWER EXTREMITY | Robert R. Moore | 1977-06-17 | Traditional | PDF ↗ |
| K770436 | EXERCISER, EXTENSOR WAND | Maddak, Inc. | 1977-04-06 | Traditional | PDF ↗ |
| K770144 | RHEUMATOID HAND GYM | Maddak, Inc. | 1977-01-28 | Traditional | PDF ↗ |
| K761313 | 4-BAR KNEE-SHIN SET-UP | Hosmer Dorrance Corp. | 1977-01-10 | Traditional | PDF ↗ |
| K761314 | FLEXION-BRAKING KNEE-SHIN ASSEMBLY | Hosmer Dorrance Corp. | 1977-01-10 | Traditional | PDF ↗ |
| K761120 | SPIN-A-PULL | Fred Sammons, Inc. | 1976-12-02 | Traditional | PDF ↗ |
| K761135 | SHORT INFLATED ROLLS | Fred Sammons, Inc. | 1976-12-02 | Traditional | PDF ↗ |
| K760305 | BALLOONS, BK-8112, 8114 | Fred Sammons, Inc. | 1976-09-08 | Traditional | PDF ↗ |
| K760304 | CANOPY, PARACHUTE, BK-8110 | Fred Sammons, Inc. | 1976-09-08 | Traditional | PDF ↗ |
Product code ION · Class I · Physical Medicine. Data: openFDA.