BTL-899M
FDA 510(k) K232937 · BTL Industries, Inc.
510(k) numberK232937
Submission
- Device name
- BTL-899M
- Applicant
- BTL Industries, Inc.
Marlborough, MA, US - Received
- September 20, 2023
- Decision date
- December 26, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
Other 510(k)s with product code IPF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M)IPF · Traditional | Weero Co., Ltd. | 06/08/2026SE |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF · Traditional | Mohammadali Nezakati | 06/02/2026SE |
| K260142 | StimelMD (SSMD) systemIPF · Special | Motion Informatics ltd. | 05/27/2026SE |
| K251083 | Compact IIIPF · Traditional | Enraf-Nonius, B.V. | 09/12/2025SE |
| K241433 | EVE Synergy (EVE-20M)IPF · Traditional | Weero Co., Ltd. | 06/04/2025SE |
| K241488 | TrainFES AdvanceIPF · Traditional | Trainfes | 02/05/2025SE |
| K240348 | Quantum Mitohormesis (QMT) (M2101)IPF · Abbreviated | Quantumtx Pte. , Ltd. | 12/19/2024SE |
| K240992 | eMVFit (MVF-10M)IPF · Traditional | Weero Co., Ltd. | 10/10/2024SE |
| K240234 | BTL-899MSIPF · Traditional | BTL Industries, Inc. | 08/17/2024SE |
| K233098 | MYOTouch Muscle StimulatorIPF · Traditional | Sunmed, LLC | 08/02/2024SE |
More from Sunmed, LLC
| 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-899M cleared by the FDA?
BTL-899M (K232937) received a 510(k) decision of Substantially Equivalent on December 26, 2023, 97 days after the submission was received.
What is the product code of K232937?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.