The Bio-Tek Uw-Ii
FDA 510(k) K862932 · Bio-Tek Instruments, Inc.
510(k) numberK862932
Submission
- Device name
- The Bio-Tek Uw-Ii
- Applicant
- Bio-Tek Instruments, Inc.
Winooski, VT, US - Received
- August 4, 1986
- Decision date
- September 25, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IMJ – Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5290
- Specialty
- Physical Medicine
Other 510(k)s with product code IMJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252963 | BTL-899TTIMJ · Traditional | BTL Industries, Inc. | 06/12/2026SE |
| K250376 | ViVYIMJ · Traditional | Viatherm Therapeutics, LLC | 11/05/2025SE |
| K243112 | Curapuls 670IMJ · Traditional | Enraf-Nonius, B.V. | 06/25/2025SE |
| K223620 | Reprieve by RegenesisTMIMJ · Traditional | Regenesis Biomedical, Inc. | 05/24/2023SE |
| K182363 | BTL-703IMJ · Traditional | BTL Industries, Inc. | 01/24/2019SE |
| K173300 | ViaTherm BOOSTIMJ · Traditional | Viatherm Therapeutics, LLC | 05/01/2018SE |
| K162240 | ProMedTek Model C1400 Shortwave Diathermy DeviceIMJ · Traditional | Promedtek, Inc. | 11/17/2016SE |
| K161862 | ThermoProIMJ · Traditional | Zimmer Medizinsysteme GmbH | 11/14/2016SE |
| K153456 | Megapulse III Shortwave DiathermyIMJ · Traditional | Accelerated Care Plus | 06/14/2016SE |
| K131926 | ThermopulseIMJ · Traditional | Ibramed Equipamentos Medicos | 07/24/2014SE |
More from Ibramed Equipamentos Medicos
| 510(k) | Device | Decision |
|---|---|---|
| K973609 | IDA-4 and Ipt-McFRN · Traditional | 12/18/1997ST |
| K971273 | Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EFDQA · Traditional | 10/08/1997SE |
| K961862 | Models IDA-2 Plus and IPT-1FRN · Traditional | 02/26/1997ST |
| K954391 | Models QED-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load…DRL · Traditional | 11/17/1995SE |
| K953710 | ELX808 Automated Microplate ReadersJJQ · Traditional | 10/25/1995SE |
| K953572 | ELX800UVJJQ · Traditional | 10/19/1995SE |
| K950104 | ELX800 and EL800 Automated Microplate ReadersJJQ · Traditional | 03/21/1995SE |
| K942923 | Ceres 900C & Ceres UV900CJJQ · Traditional | 02/06/1995SE |
| K944257 | Lionheart 3 Multi-Parameter SimulatorDRT · Traditional | 09/21/1994SE |
| K933519 | Index SPO2 SimulatorDQA · Traditional | 09/01/1994SE |
Questions and answers
When was The Bio-Tek Uw-Ii cleared by the FDA?
The Bio-Tek Uw-Ii (K862932) received a 510(k) decision of Substantially Equivalent on September 25, 1986, 52 days after the submission was received.
What is the product code of K862932?
The FDA product code is IMJ – Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5290.