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#
- 3013562453
- 3013735158
- 3019577501
- 3000215556
- 1926174
- 3009437400
- 1721293
- 3018448099
- 3025350087
- 3030465168
- 3014659326
- 3005200548
- 3040314796
- 1832894
- 3004756871
- 3035641506
- 3038636181
- 3005492707
- 3018455773
- 3038319732
- 3014539793
- 3011654863
- 3043149902
- 3010511300
- 3015968545
- 3012365608
- 3006895494
- 3038166027
- 3002808227
- 3017491419
- 3015142940
- 3016162044
- 3034731361
- 3017887928
- 3023339107
- 3025104654
- 3000099306
- 3016458380
- 3037003917
- 3011564440
- 3032597205
- 3010486573
- 3009129782
- 3043655600
- 3007816986
- 3014326210
- 3013689783
- 3027520359
- 3025936823
- 3024838923
- 3034288049
- 3019623342
- 3007744197
- 3002849858
- 3017610929
- 3043011436
- 3025306332
- 3004938911
- 3027601982
- 3014606355
- 3016425406
- 3010626066
- 3013517454
- 3013787796
- 3012833018
- 3042261334
- 3009156060
- 3010391227
- 3021334093
- 3033918960
- 3043140679
- 3007075140
- 3012841710
- 3040985888
- 3030977408
- 3026322014
- 3016951909
- 3021594345
- 3043149162
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 |