510(k) K801453
- Device
- FINGER, HAND & WRIST EXERCISER
- Applicant
- ROBERT W. SLACK
- 510(k) number
- K801453
- Product code
- ION
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-04
- Date received
- 1980-06-24
- 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#
- 3008264111
- 1929833
- 3005497907
- 3010675897
- 3010605307
- 9681624
- 3017199264
- 3004511013
- 3006728994
- 3014020423
- 3011171243
- 3010168049
- 3010163710
- 8022077
- 3015536186
- 3007289408
- 3009109991
- 3010987649
- 1319061
- 3042194239
- 3034731509
- 3029303823
- 3024550917
- 3043088937
- 1723702
- 3012025829
- 3014982318
- 1000337819
- 9612061
- 3007218972
- 3017207990
- 3008344682
- 3005555653
- 3027939
- 3017259276
- 3010394125
- 8020836
- 3023083058
- 3007889024
- 3034729907
- 3001650535
- 3003132519
- 8021995
- 8021957
- 3017268832
- 3009097552
- 2183634
- 3005037196
- 3021373887
- 3004526603
- 3009674182
- 1181047
- 1000159372
- 8040255
- 3031258235
- 2432177
- 3005822857
- 3011508500
- 3009759417
- 3010605276
- 1218386
- 3027645317
- 3005214422
- 3007280950
- 1832562
- 3017488851
- 3008485769
- 3012697061
- 3042657413
- 3011225385
- 3017637993
- 1932056
- 3010675856
- 3003781173
- 3023189540
- 2242467
- 3022568093
- 3016099060
- 3010171505
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 |
| K823620 | PLASTIC ELASTOMER IN CUBE FORM EXERCISE | Fred Sammons, Inc. | 1982-12-22 |
Legacy Summary#
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FDA Review#
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