510(k) K013244
- Device
- COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE
- Applicant
- Med Gen, Inc.
- 510(k) number
- K013244
- Product code
- FQM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-07
- Date received
- 2001-09-28
- Regulation
- 880.5075
- Classification name
- Bandage, Elastic
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- THEDORE BARASH
- Address
- 7284 W. Palmetto Pk. Rd. Boca Raton FL US 33433 33433
FDA Registration Numbers#
- 3010700223
- 3004537835
- 3008806809
- 3008973893
- 1036781
- 3011568703
- 3032911850
- 1038963
- 3015745029
- 8020659
- 3003418325
- 3008932266
- 3005951296
- 3005423373
- 1720929
- 3038295725
- 3013857401
- 3015173437
- 3016758972
- 3033920063
- 3013226
- 3014313758
- 9680934
- 3010872396
- 3012680643
- 3013525506
- 3027481895
- 3005037196
- 3005132313
- 3012581593
- 3009486864
- 2110420
- 3004753358
- 3006993855
- 2027062
- 9611959
- 3041329419
- 3015142721
- 3031582449
- 3015214015
- 3030143815
- 9680222
- 3012137459
- 3010621964
- 3026263452
- 3038637162
- 1060680
- 3013632692
- 3035642068
- 1221770
- 3004967086
- 3006517436
- 3037040712
- 3007327603
- 3044466317
- 3045816902
- 3015379055
- 3013919644
- 3007607706
- 2530957
- 3002468342
- 3012017650
- 3036779619
- 3008485841
- 3030528528
- 3010383831
- 3004111573
- 3009865268
- 3015937050
- 3031582434
- 3009761558
- 3012541976
- 3004551550
- 1063974
- 3023141635
- 1420763
- 2183164
- 3021013122
- 3005012805
Source Documents#
Other 510(k) Records For Product Code FQM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040936 | PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE | Leda Co., Ltd. | 2004-05-03 |
| K040054 | BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE | Theodore Barash | 2004-04-27 |
| K952738 | SKIN SAVER SYSTEMS | Skin Saver Systems, Inc. | 1995-09-29 |
| K872868 | ASPEN ESMARK BANDAGE | Aspen Laboratories, Inc. | 1987-07-31 |
| K840107 | TUBE-BANDAGE FOR HUMAN DIGITS 200 | Zens Health Care Products | 1984-04-25 |
| K831728 | MEDICALEX | Medicalex | 1984-01-09 |
| K830622 | ORTHO WRAP | Fast Wrap Co., Inc. | 1983-06-20 |
| K831551 | COMPRESSOGRIP TUBULAR ELASTIC BANDAGE | Fred Sammons, Inc. | 1983-06-07 |
| K820141 | BIAS STOCKINETTE | Stan-Pak Ent. | 1982-02-05 |
| K820142 | TUBULAR STOCKINETTE | Stan-Pak Ent. | 1982-02-05 |
| K820094 | ELASTIC BANDAGE | Stan-Pak Ent. | 1982-01-29 |
| K811173 | STRUVA & MEDI | Weco | 1981-06-18 |
| K810137 | SOF-BAND HIGH STRETCH BANDAGES | Johnson & Johnson Professionals, Inc. | 1981-02-17 |
| K802991 | ROLL STRETCH GAUZE | Abco Dealers, Inc. | 1980-12-30 |
| K802992 | ELASTIC GAUZE | Abco Dealers, Inc. | 1980-12-30 |