510(k) K221865
- Device
- BTL-094
- Applicant
- BTL Industries, Inc.
- 510(k) number
- K221865
- Product code
- ISA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-14
- Date received
- 2022-06-27
- Regulation
- 890.5660
- Classification name
- Massager, Therapeutic, Electric
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- David Chmel
- Address
- 362 Elm St. Marlborough MA US 01752 01752
FDA Registration Numbers#
- 3005405999
- 3003062321
- 3015968545
- 3014110830
- 3012217421
- 3010511300
- 3022028624
- 3014388884
- 3014527840
- 3012833018
- 3008361502
- 3016458459
- 3007075140
- 3013440654
- 3027057394
- 3033530347
- 3010391227
- 1217202
- 3005492707
- 3038622006
- 3012025829
- 3033524191
- 3016879560
- 3025432379
- 3009862779
- 3013730933
- 3015527739
- 3026753375
- 3017618900
- 3018317166
- 3004756871
- 3013851422
- 3010297540
- 3007674911
- 3015738761
- 3012278343
- 3011962812
- 3005740303
- 3025702939
- 3018455773
- 3017887928
- 3007047889
- 3010256111
- 3012184208
- 3007816986
- 3007962592
- 3018994966
- 3003590412
- 3008729892
- 3006546131
- 3033905868
- 3014158749
- 3008959444
- 3035371866
- 3006624940
- 3042261334
- 9612147
- 3013689783
- 3034204485
- 3008643402
- 3034288049
- 3015217632
- 3009690509
- 3003832641
- 3018123168
- 3012289707
- 3040138099
- 3021635975
- 3025414368
- 3014326210
- 3019015047
- 9613347
- 3009072217
- 3012365608
- 3026297283
- 3027436335
- 3009617411
- 3012512142
- 3004264602
Source Documents#
Other 510(k) Records For Product Code ISA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243488 | VMAT PRO | Termosalud | 2025-02-06 |
| K240358 | ShockPhysio Mobile (model SW3200 Basic) | Shenzhen Dongdixin Technology Co., Ltd. | 2024-06-05 |
| K210166 | Omnispec ED1000 | Medispec, Ltd. | 2023-01-27 |
| K213120 | OW100S (model OW100S-US) | Tissue Regeneration Technologies, LLC Dba AS Softwave Trt | 2022-10-12 |
| K220538 | DolorClast Radial | E.M.S Electro Medical Systems S.A | 2022-07-11 |
| K210451 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | 2021-05-05 |
| K182682 | OrthoGold 100 | Tissue Regeneration Technologies | 2018-12-21 |
| K173692 | D-Actor 200 Vibration Massage System | Storz Medical AG | 2018-04-13 |
| K053225 | CELLU M6 KEYMODULE I | Lpg One, Inc. | 2006-11-06 |
| K030876 | CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM | Cynosure, Inc. | 2004-01-22 |
| K002908 | JET THERAPY | Jet Therapy | 2001-08-30 |
| K990445 | LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR | Lpg USA, Inc. | 2000-01-18 |
| K952990 | SPIN ROLLERE | Kinsei Shiatsu, Inc. | 1995-09-29 |
| K952041 | BODYFLEX MASSAGER | Truro'S Ent. | 1995-08-14 |
| K950411 | RELAXU-1 | Kinsei Shiatsu, Inc. | 1995-08-02 |