BTL Elite
FDA 510(k) K120093 · BTL Industries, Inc.
510(k) numberK120093
Submission
- Device name
- BTL Elite
- Applicant
- BTL Industries, Inc.
Waltham, MA, US - Received
- January 12, 2012
- Decision date
- October 5, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K260691 | BTL-699OBP · Traditional | 08/23/2026SE |
| K252963 | BTL-899TTIMJ · Traditional | 06/12/2026SE |
| K253750 | BTL-785NEHGEI · Traditional | 03/17/2026SE |
| K252561 | BTL-754FFGEX · Traditional | 02/18/2026SE |
| K250309 | BTL-199QPL · Traditional | 08/07/2025SE |
| K243290 | BTL-785MJNUW · Traditional | 05/09/2025SE |
| K241516 | BTL-398KPI · Traditional | 02/10/2025SE |
| K241270 | BTL-754GEX · Traditional | 01/30/2025SE |
| K242532 | BTL-785BNF-ENFO · Traditional | 12/13/2024SE |
| K240234 | BTL-899MSIPF · Traditional | 08/17/2024SE |
Questions and answers
When was BTL Elite cleared by the FDA?
BTL Elite (K120093) received a 510(k) decision of Substantially Equivalent on October 5, 2012, 267 days after the submission was received.
What is the product code of K120093?
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.