510(k) K905299
- Device
- ROMFLEX REHABILITATION EQUIPMENT
- Applicant
- DYNA FLEX, INTL.
- 510(k) number
- K905299
- Product code
- BXB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-12-31
- Date received
- 1990-11-28
- Regulation
- 890.5380
- Classification name
- Exerciser, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- HARRISON BEAL
- Address
- 151 E. Broad St. Clinton TN US 37716 37716
FDA Registration Numbers#
- 3008264111
- 9681904
- 9680413
- 2311923
- 3007084636
- 3018993530
- 3036496458
- 3011171243
- 3017555752
- 3014739961
- 2029188
- 3005404127
- 3034993050
- 1723702
- 3012841710
- 3017899143
- 3013730933
- 3042285056
- 3013697488
- 3014209670
- 3013515165
- 1223754
- 3002761514
- 8020836
- 1530917
- 3015131233
- 2510425
- 8021957
- 3009649442
- 3007797030
- 3021233816
- 3021373887
- 3011539161
- 3004733458
- 9612147
- 3008812560
- 3015280549
- 3004751498
- 3008887767
- 3004116008
- 3007080244
- 3009684923
- 3016678950
- 3008381107
- 3009411363
- 3010675856
- 3006400320
- 3016099060
- 2000019555
- 1911273
- 3007740591
- 3008309560
- 3014527921
- 9616789
- 3010483249
- 3030379943
- 3006116732
- 3014246565
- 3033511104
- 3004096515
- 3010128811
- 3012251300
- 3015005470
- 3004905643
- 3006750942
- 3013383022
- 3003454229
- 3012316249
- 1043214
- 3030643364
- 3010898730
- 3005180774
- 3008351005
- 3010452421
- 2431314
- 3017264244
- 3013551163
- 1124832
- 3032587540
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BXB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072887 | G-TRAINER MEDICAL | Alter-G, Inc. | 2008-01-25 |
| K003272 | FLO-BOOT | Discovery Group, LLC | 2001-04-04 |
| K952975 | ANKLE CALF EXERCISER PHLEBOPUMP | Prevent Products, Inc. | 1996-09-25 |
| K953456 | E-Z FLEX | Fluid Motion Biotechnologies, Inc. | 1996-01-26 |
| K955106 | BTE CPM-20 | Baltimore Therapeutic Equipment Co. | 1995-12-29 |
| K955105 | BTE CPM-10 | Baltimore Therapeutic Equipment Co. | 1995-12-29 |
| K951028 | HAMEX TWO | Northern Orthopaedic Products, Inc. | 1995-12-11 |
| K950755 | FLEXMATE K500 | Breg, Inc. | 1995-10-05 |
| K951029 | HAMEX ONE | Northern Orthopaedic Products, Inc. | 1995-09-15 |
| K945733 | AQUAHAB, MODEL 120-72-101 | Aquarius Electronics, Inc. | 1995-09-15 |
| K950682 | W2 WRIST CPM UNIT | Toronto Medical Corp. | 1995-09-13 |
| K952369 | KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE | Physicians Consulting, Inc. | 1995-08-07 |
| K945690 | BACKCYCLER CPM(TM) | Ergomedics, Inc. | 1995-06-22 |
| K946169 | ACTIC 2002 | North Atlantic Rehabilitation, Inc. | 1995-06-15 |
| K945824 | GALAXY MD SERIES THERAPYPOOLS | Galaxy Aquatics, Inc. | 1995-04-05 |
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