510(k) K792642
- Device
- The Variable Load Kenetic Energizer
- Applicant
- W.F. POGUE
- 510(k) number
- K792642
- Product code
- ION
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-01-28
- Date received
- 1979-12-26
- 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#
- 1000337819
- 9615313
- 3042928305
- 3010605276
- 3005587124
- 3014020423
- 3015972815
- 3004099452
- 3011225385
- 3008309560
- 3009425025
- 3003123807
- 3043138885
- 3011421558
- 9710514
- 3022568093
- 3014246565
- 3019505063
- 3009749942
- 3003681032
- 3042657413
- 3005497907
- 3009884893
- 3003781173
- 9681624
- 3009273990
- 3012970776
- 3027939
- 3015821396
- 3021373887
- 3012697061
- 3006408818
- 3043667885
- 3044855033
- 3016195240
- 3014266593
- 3018995133
- 3001650535
- 2128677
- 3005214422
- 3010171505
- 3012025829
- 3016492840
- 3031258235
- 3009020186
- 3008344682
- 3017259276
- 3027645317
- 3011659673
- 3009759417
- 3012316249
- 8032044
- 3012579728
- 3044905064
- 9612061
- 3024550917
- 2242467
- 8043316
- 3007280950
- 2921577
- 3018100917
- 3010163710
- 3013591868
- 3005822857
- 3035385409
- 3007222468
- 3013473968
- 3004956798
- 3021656665
- 2431314
- 3004526603
- 3006050793
- 3011506263
- 3044710870
- 3010675856
- 3042901434
- 3048147324
- 3030539818
- 3016147813
- 3017268832
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 |