510(k) K250309
- Device
- BTL-199
- Applicant
- BTL Industries, Inc.
- 510(k) number
- K250309
- Product code
- QPL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-07
- Date received
- 2025-02-03
- Regulation
- 882.5890
- Classification name
- Electromagnetic Stimulator, Pain Relief
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- David Chmel
- Address
- 362 Elm St. Marlborough MA US 01752 01752
FDA Registration Numbers#
- 3012168464
- 9613462
- 8021774
- 3012352782
- 3015617003
- 3005545216
- 3035374386
Source Documents#
Other 510(k) Records For Product Code QPL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | The Magstim Company Limited | 2025-07-03 |
| K241785 | StarFormer (M008-3T) | Fotona D.O.O. | 2025-03-27 |
| K233364 | Axon Therapy | Neuralace Medical, Inc. | 2024-01-10 |
| K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption | Tonica Elektronik A/S | 2023-08-25 |
| K210021 | Axon Therapy | Neuralace Medical, Inc. | 2021-06-11 |