510(k) K840551
- Device
- MOBILIZER
- Applicant
- LOSSING ORTHOPEDIC, INC.
- 510(k) number
- K840551
- Product code
- ION
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-03-23
- Date received
- 1984-02-08
- 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#
- 3021235837
- 3008560399
- 3042657413
- 3043479340
- 3017003778
- 3009097552
- 3030452839
- 9612061
- 8021995
- 3015339737
- 3023189540
- 3009282549
- 3001452523
- 3009020186
- 3008960494
- 3007222468
- 3007913191
- 3016162044
- 3015727296
- 1832562
- 3042194239
- 3011171243
- 3003718149
- 1526863
- 3043088937
- 3005037196
- 3035385409
- 9615313
- 3005621376
- 3014020423
- 3026036993
- 3009273990
- 3010987649
- 1119903
- 3027939
- 3012579728
- 8032044
- 2435707
- 3003775414
- 3043749706
- 3005497907
- 3005569927
- 3007518294
- 1043214
- 3016099060
- 3022106572
- 3008351005
- 9618009
- 3015821396
- 3013132310
- 3015972815
- 3017199264
- 1422443
- 3014982318
- 3014246565
- 3017268832
- 3010664759
- 3018995133
- 3008264111
- 3005587124
- 3024550917
- 3012316249
- 3004034546
- 1058052
- 8020836
- 2131610
- 3031209
- 8022890
- 3009425025
- 3010310816
- 3021011196
- 3014266593
- 3003132519
- 2432177
- 3015142815
- 3019505063
- 3015474594
- 3007278668
- 3042148166
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 |
| 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 |
| K823619 | PLASTIC ELASTOMER ENCASED IN TERRY CLOTH | Fred Sammons, Inc. | 1982-12-22 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases