510(k) K240234
- Device
- BTL-899MS
- Applicant
- BTL Industries, Inc.
- 510(k) number
- K240234
- Product code
- IPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-17
- Date received
- 2024-01-29
- Regulation
- 890.5850
- Classification name
- Stimulator, Muscle, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- David Chmel
- Address
- 362 Elm St. Marlborough MA US 01752 01752
FDA Registration Numbers
- 3003895865
- 3014774380
- 3004081884
- 3004146401
- 3010402752
- 3004264602
- 1528161
- 3012651177
- 3013917867
- 3011466827
- 3010162782
- 1054713
- 8040537
- 3011564440
- 3012386142
- 3003573572
- 3043657394
- 3010362721
- 3020683829
- 3012981024
- 3017450375
- 3008273892
- 3007731000
- 3012352782
- 3027241812
- 1911273
- 2023152
- 3006153348
- 8022890
- 3017866822
- 3009437400
- 3017264244
- 3035374386
- 3011267903
- 3003740945
- 3012168464
- 3030539046
- 3008525454
- 3007543044
- 3001676837
- 9613462
- 3010405397
- 3005170249
- 9710580
- 3010280625
- 9611612
- 3042228064
- 3019822804
- 3005569927
- 3012316249
- 2013558
- 3007502541
- 3033847811
- 3043011436
- 3010511300
- 3013602304
- 3010583453
- 3023339107
- 3013069546
- 3015617003
- 3029312829
- 3016670292
- 3011782009
- 3016087653
- 3031233199
- 3032062344
- 3016512343
- 3013077196
- 3033530347
- 3019356418
- 3038295706
- 9615033
- 3043153468
- 3011191255
- 3004733458
- 1417592
- 3013671142
- 3043012240
- 3011905669
Source Documents
Other 510(k) Records For Product Code IPF
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|---|---|---|---|
| K251083 | Compact II | Enraf-Nonius, B.V. | 2025-09-12 |
| K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | 2025-06-04 |
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| K233098 | MYOTouch Muscle Stimulator | Sunmed, LLC | 2024-08-02 |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | Edan Instruments, Inc. | 2024-05-16 |
| K233926 | accufit | Mettler Electronics Corporation | 2024-03-21 |
| K233485 | M-Wave | Zynex Medical, Inc. | 2024-01-26 |
| K232937 | BTL-899M | BTL Industries, Inc. | 2023-12-26 |
| K230701 | Stim2Go | PAJUNK GmbH Medizintechnologie | 2023-11-24 |
| K231440 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. | 2023-11-03 |
| K223027 | NeuroTrigger Basic (NTB) | Neurotrigger | 2023-10-10 |
| K223802 | accufit | Mettler Electronics Corporation | 2023-10-06 |
| K221274 | StarFormer, TightWave | Fotona D.O.O. | 2023-09-29 |