Back in Action Compression & Support with Magnets for the Lower Back, Knee and Ankle
FDA 510(k) K040054 · Theodore Barash
510(k) numberK040054
Submission
- Device name
- Back in Action Compression & Support with Magnets for the Lower Back, Knee and Ankle
- Applicant
- Theodore Barash
Delray Beach, FL, US - Received
- January 12, 2004
- Decision date
- April 27, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FQM – Bandage, Elastic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5075
- Specialty
- General Hospital
Other 510(k)s with product code FQM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040936 | Petit Silma Elastic Bandage with Germanium/Titanium OxideFQM · Traditional | Leda Co., Ltd. | 05/03/2004SE |
| K013244 | Comfortcare Compression Support Witih Magnets and Aegis Microbe Shield Comfortcare…FQM · Traditional | Med Gen, Inc. | 12/07/2001SE |
| K952738 | Skin Saver SystemsFQM · Traditional | Skin Saver Systems, Inc. | 09/29/1995SE |
| K872868 | Aspen Esmark BandageFQM · Traditional | Aspen Laboratories, Inc. | 07/31/1987SE |
| K840107 | Tube-Bandage for Human Digits 200FQM · Traditional | Zens Health Care Products | 04/25/1984SE |
| K831728 | MedicalexFQM · Traditional | Medicalex | 01/09/1984SE |
| K830622 | Ortho WrapFQM · Traditional | Fast Wrap Co., Inc. | 06/20/1983SE |
| K831551 | Compressogrip Tubular Elastic BandageFQM · Traditional | Fred Sammons, Inc. | 06/07/1983SE |
| K820142 | Tubular StockinetteFQM · Traditional | Stan-Pak Ent. | 02/05/1982SE |
| K820141 | Bias StockinetteFQM · Traditional | Stan-Pak Ent. | 02/05/1982SE |
Questions and answers
When was Back in Action Compression & Support with Magnets for the Lower Back, Knee and Ankle cleared by the FDA?
Back in Action Compression & Support with Magnets for the Lower Back, Knee and Ankle (K040054) received a 510(k) decision of Substantially Equivalent on April 27, 2004, 106 days after the submission was received.
What is the product code of K040054?
The FDA product code is FQM – Bandage, Elastic, a Class I (low risk) device regulated under 21 CFR 880.5075.