Bodystay
FDA 510(k) K951097 · Bodystat , Ltd.
510(k) numberK951097
Submission
- Device name
- Bodystay
- Applicant
- Bodystat , Ltd.
British Isles, BR - Received
- March 8, 1995
- Decision date
- November 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DSB – Plethysmograph, Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
Other 510(k)s with product code DSB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)DSB · Traditional | ImpediMed Limited | 08/17/2026SE |
| K250634 | BCM2-Body Composition MonitorDSB · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 11/24/2025SE |
| K243727 | Re:BalansDSB · Traditional | Mode Sensors AS | 10/16/2025SE |
| K250922 | Edema Guard Monitor (EGM) CardioSet-001DSB · Traditional | Cardioset Medical , Ltd. | 09/09/2025SE |
| K232089 | SOZO ProDSB · Traditional | ImpediMed Limited | 10/17/2023SE |
| K223217 | Zynex Monitoring System, Model CM-1600DSB · Traditional | Zynex Medical, Inc. | 06/16/2023SE |
| K211585 | Bodyport Cardiac ScaleDSB · Traditional | Bodyport, Inc. | 07/29/2022SE |
| K203473 | SozoDSB · Traditional | ImpediMed Limited | 04/19/2021SE |
| K193410 | SOZO Body Fluid AnalyzerDSB · Traditional | ImpediMed Limited | 10/02/2020SE |
| K191697 | Cardiac Monitor 1500DSB · Traditional | Zynex Medical, Inc. | 02/21/2020SE |
More from Zynex Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K082255 | Quadscan 4000 Body Body Composition, Fluid & Illness/Segmental Monitoring UnitMNW · Traditional | 02/07/2011SE |
| K082254 | Modification to Bodystat 1500MDD Body Composition Monitoring UnitMNW · Traditional | 02/07/2011SE |
| K082253 | Bodystat 1500 Body Composition Monitoring UnitMNW · Traditional | 11/25/2008SE |
| K002835 | BodystatMNW · Traditional | 07/03/2001SE |
| K994242 | Bodystat 1500MDD Body Composition Monitoring UnitMNW · Traditional | 03/15/2000SE |
| K980971 | Bodystat Dualscan 2005MNW · Traditional | 06/11/1998SE |
| K971554 | BodystatMNW · Traditional | 11/26/1997SE |
Questions and answers
When was Bodystay cleared by the FDA?
Bodystay (K951097) received a 510(k) decision of Substantially Equivalent on November 22, 1995, 259 days after the submission was received.
What is the product code of K951097?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.