The Bte WS30
FDA 510(k) K933611 · Baltimore Therapeutic Equipment Co.
510(k) numberK933611
Submission
- Device name
- The Bte WS30
- Applicant
- Baltimore Therapeutic Equipment Co.
Hanover, MD, US - Received
- July 19, 1993
- Decision date
- June 20, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ISD – Exerciser, Measuring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5360
- Specialty
- Physical Medicine
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| K183296 | REAL Immersive SystemISD · Traditional | Penumbra, Inc. | 03/18/2019SE |
| K143512 | ActiSpec Activity MonitorISD · Traditional | Sleep Modus, Inc. | 08/26/2015SE |
| K112121 | Ergoselect/GeISD · Traditional | Ergoline GmbH | 10/31/2012SE |
| K080545 | ActitrainerISD · Traditional | Actigraph, LLC | 07/24/2008SE |
| K053078 | Ergoselect 100 K/P, Ergoselect 200 K/PISD · Traditional | Ergoline GmbH | 04/27/2006SE |
| K990866 | Quinton Medtrack CR Plus TreadmillISD · Traditional | Quinton, Inc. | 04/29/1999SE |
| K990813 | RehcorISD · Traditional | Electromed Corp. | 04/12/1999SE |
| K962855 | ULE-2, MULE-2, Hand Accessory KitISD · Traditional | Penny and Giles Biometrics , Ltd. | 12/11/1996SE |
| K952163 | David Back Clinic SystemISD · Traditional | Kinetic Resources, Inc. | 08/12/1996SE |
More from Kinetic Resources, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955106 | Bte CPM-20BXB · Traditional | 12/29/1995SE |
| K955105 | Bte CPM-10BXB · Traditional | 12/29/1995SE |
| K925225 | The Bte Vector; Analysis System for the Low BackKQX · Traditional | 06/27/1994SE |
| K924414 | The Bte Dynamic LiftIKK · Traditional | 02/12/1993SE |
| K895881 | MotionspectLXW · Traditional | 04/10/1990SE |
| K800007 | Work SimulatorBXB · Traditional | 01/21/1980SE |
Questions and answers
When was The Bte WS30 cleared by the FDA?
The Bte WS30 (K933611) received a 510(k) decision of Substantially Equivalent on June 20, 1994, 336 days after the submission was received.
What is the product code of K933611?
The FDA product code is ISD – Exerciser, Measuring, a Class II (moderate risk) device regulated under 21 CFR 890.5360.