BTL Industries, Inc
Marlborough, MA, US
BTL Industries, Inc appears in FDA device records in Marlborough, MA. FDA records list 45 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 45 510(k) clearances for BTL Industries, Inc between 2009 and 2026. The busiest year on record is 2015, with 6. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 6 |
| 2016 | 4 |
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 3 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 5 |
| 2024 | 5 |
| 2025 | 4 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252963 | BTL-899TT | IMJ | Substantially Equivalent | |
| K253750 | BTL-785NEH | GEI | Substantially Equivalent | |
| K252561 | BTL-754FF | GEX | Substantially Equivalent | |
| K250309 | BTL-199 | QPL | Substantially Equivalent | |
| K243290 | BTL-785MJ | NUW | Substantially Equivalent | |
| K241516 | BTL-398 | KPI | Substantially Equivalent | |
| K241270 | BTL-754 | GEX | Substantially Equivalent | |
| K242532 | BTL-785BNF-E | NFO | Substantially Equivalent | |
| K240234 | BTL-899MS | IPF | Substantially Equivalent | |
| K233849 | BTL-499 | GEI | Substantially Equivalent | |
| K233604 | BTL-785S | GEI | Substantially Equivalent | |
| K230657 | BTL-99-OC | QCI | Substantially Equivalent | |
| K232937 | BTL-899M | IPF | Substantially Equivalent | |
| K230467 | BTL-899F | GEI | Substantially Equivalent | |
| K232172 | BTL-785BNF Handpiece | NFO | Substantially Equivalent | |
| K222556 | BTL-785X | GEI | Substantially Equivalent | |
| K221865 | BTL-094 | ISA | Substantially Equivalent | |
| K211639 | BTL-785W | GEI | Substantially Equivalent | |
| K212723 | BTL-995-rTMS | OBP | Substantially Equivalent | |
| K213344 | BTL-899A | GEI | Substantially Equivalent | |
| K211107 | BTL-899 FP | GEI | Substantially Equivalent | |
| K190456 | BTL 799-2L | NGX | Substantially Equivalent | |
| K190023 | BTL-084 | PBX | Substantially Equivalent | |
| K182363 | BTL-703 | IMJ | Substantially Equivalent | |
| K180359 | BTL-FR2000 | GEI | Substantially Equivalent | |
| K181497 | HPM-6000UF | KPI | Substantially Equivalent | |
| K182106 | BTL 799-2T | NGX | Substantially Equivalent | |
| K180813 | BTL 799-2 | NGX | Substantially Equivalent | |
| K163165 | AM-100 | NGX | Substantially Equivalent | |
| K163176 | Exilis XP II | PBX | Substantially Equivalent | |
| K162010 | HPM-6000U | KPI | Substantially Equivalent | |
| K160992 | HPM-6000 | IPF | Substantially Equivalent | |
| K161551 | TR-100 | PBX | Substantially Equivalent | |
| K152731 | XP1100 RF | GEI | Substantially Equivalent | |
| K150353 | BTL-4000 | IMG | Substantially Equivalent | |
| K150720 | XP3000 | PBX | Substantially Equivalent | |
| K143559 | XP1000 RF | GEI | Substantially Equivalent | |
| K150051 | Exilite | ONF | Substantially Equivalent | |
| K143109 | XP300 | GEI | Substantially Equivalent | |
| K143040 | Exilis XP | PBX | Substantially Equivalent | |
| K134040 | BTL-9000; BTL-9000 RADIOFREQUENCY MODULE | OLI | Substantially Equivalent | |
| K122966 | XP200 | GEI | Substantially Equivalent | |
| K120093 | BTL ELITE | IMJ | Substantially Equivalent | |
| K100310 | BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS | MWJ | Substantially Equivalent | |
| K092191 | EXILIS, MODEL 5000 | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006976359 | 3006976359 | BTL Industries, Inc | 362 Elm Street, Marlborough, MA 01752 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- MWJElectrocardiograph, Ambulatory (Without Analysis)
- QPLElectromagnetic Stimulator, Pain Relief
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- OLIFat Reducing Low Level Laser
- ISAMassager, Therapeutic, Electric
- PBXMassager, Vacuum, Radio Frequency Induced Heat
- GEXPowered Laser Surgical Instrument
- ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect
- KPIStimulator, Electrical, Non-Implantable, For Incontinence
- IPFStimulator, Muscle, Powered
- NUWStimulator, Muscle, Powered, Dental
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
- NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- OBPTranscranial Magnetic Stimulator
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets BTL Industries, Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain