FORTE
FDA 510(k) clearance K953614 · decided 1995-10-27
Clearance details
- K-number
- K953614
- Device name
- FORTE
- Applicant
- Chattanooga Group, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1995-08-03
- Decision date
- 1995-10-27
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- IMG
- Device class
- 2
- Regulation number
- 890.5860
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Hixson, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Chattanooga Group
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ultrasound Therapy Workstation (XMS-UET2) (K244041) | Xemis Medical Technology (Shenzhen) Co., Ltd. | 2025-10-07 |
| OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System (K153559) | Accelerated Care Plus (Acp) | 2016-08-26 |
| ComboRehab (K150436) | Shenzhen Dongdixin Technology Co., Ltd. | 2015-11-13 |
| BTL-4000 (K150353) | BTL Industries, Inc. | 2015-11-13 |
| SONICSTIMU COMBO THERAPEUTIC DEVICE (K120217) | Shenzhen Dongdixin Technology Co., Ltd. | 2012-11-21 |
| SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM (K121059) | Zimmer Medizinsystems GmbH | 2012-08-07 |
| FUTURA (K102524) | Dr. Oliver Wenker, M.D., M.B.A. | 2011-11-03 |
| SONICATOR PLUS 920 (K111482) | Mettler Electronics Corp. | 2011-08-25 |
| WINSTIM (K102190) | Johari Digital Healthcare , Ltd. | 2011-03-17 |
| CT2011 SONICSTIMU PAIN RELIEF DEVICE (K092627) | Shenzhen Dongdixin Technology Co., Ltd. | 2010-01-14 |
| SONICATOR PLUS 940, MODEL ME940 (K071137) | Mettler Electronics Corp. | 2007-08-01 |
| TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM (K063728) | Alfa Tech Medical Systems, Ltd. | 2007-04-04 |
Recalls involving this device
No recalls on record reference this clearance.