510(k) K761313
- Device
- 4-BAR KNEE-SHIN SET-UP
- Applicant
- HOSMER DORRANCE CORP.
- 510(k) number
- K761313
- Product code
- ION
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-01-10
- Date received
- 1976-12-13
- Regulation
- 890.5370
- Classification name
- Exerciser, Non-measuring
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3003123807
- 1526863
- 3008887767
- 2432177
- 3017003778
- 3011806255
- 3043138885
- 3011508500
- 3006061749
- 1058602
- 9615313
- 3023189540
- 3011506263
- 3016796158
- 3010394125
- 3017268832
- 3040387920
- 3006408818
- 2131610
- 3012316249
- 1932056
- 3034535
- 3004511013
- 3044855033
- 3004526603
- 8020836
- 3008264111
- 3008344682
- 3013903013
- 9618009
- 3010310816
- 3016492840
- 8022890
- 3012697061
- 3012579728
- 3009068676
- 3043749706
- 3010595915
- 3007889024
- 3009273990
- 3021593882
- 3004824601
- 3007499787
- 3010439239
- 3043127556
- 1119903
- 3004956798
- 3012970776
- 3010168049
- 1523547
- 1723702
- 3007913191
- 8032035
- 3013473968
- 3007278668
- 3010605276
- 3042148166
- 2939821
- 3021235837
- 3012307300
- 3007543044
- 3003781173
- 3033507840
- 2523764
- 3042928305
- 3009097552
- 3009425025
- 1043214
- 3005214422
- 3008311431
- 3016099060
- 3016746538
- 3008410069
- 2921577
- 3006050793
- 3004034546
- 3021656665
- 2431314
- 3008951110
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ION #
| 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 |
| K823618 | PROGRESSIVE RESISTANCE EXERCISE CUFF | Fred Sammons, Inc. | 1982-12-22 |
Legacy Summary#
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FDA Review#
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