Chattanooga Group, Inc.: FDA clearances and approvals
Chattanooga Group, Inc. has 81 FDA 510(k) clearances (first 1980, latest 2009), across 29 product codes in 5 review panels. Median 510(k) review time: 84 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 14 | 14 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 13 | 13 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 8 | 8 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 5 | 5 |
| LBB | Dynamometer, Ac-Powered | 4 | 4 |
| ITH | Equipment, Traction, Powered | 2 | 2 |
| JFB | Table, Physical Therapy, Multi Function | 2 | 2 |
| JOW | Sleeve, Limb, Compressible | 2 | 2 |
| BXB | Exerciser, Powered | 1 | 1 |
| GZI | Stimulator, Neuromuscular, External Functional | 1 | 1 |
Plus 19 more product codes.
Review panels
- Physical Medicine (51)
- Neurology (15)
- Cardiovascular (2)
- Ear, Nose and Throat (1)
- Orthopedic (1)
Most recent Chattanooga Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090632 | COMPEX REHAB | IPF | 2009-06-01 | 84 |
| K083433 | INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 | IMJ | 2009-03-18 | 118 |
| K083140 | COMPEX SPORT PLUS | NGX | 2009-02-09 | 109 |
| K070425 | VITALSTIM EXPERIA | IPF | 2007-06-11 | 118 |
| K053223 | TRITON/TRU-TRAC/TX/TRITON DTS TRACTION | ITH | 2006-02-24 | 99 |
| K051938 | TRITON/TRU-TRAC/TX TRACTION DEVICES | ITH | 2005-09-21 | 65 |
| K040662 | VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS | ILY | 2004-09-08 | 180 |
| K040285 | VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER | IMG | 2004-04-12 | 66 |
| K031077 | VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM | IMG | 2003-12-11 | 251 |
| K031116 | VECTRA (INTELECT) EPR ULTRASOUND | IMI | 2003-12-03 | 239 |
71 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Chattanooga Group, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Chattanooga Group, Inc. have?
Chattanooga Group, Inc. has 81 FDA 510(k) clearances (first 1980, latest 2009), across 29 product codes in 5 review panels.
How long does FDA take to clear Chattanooga Group, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Chattanooga Group, Inc.'s cleared 510(k)s is 84 days.
What devices does Chattanooga Group, Inc. make?
Its most frequent FDA product codes are IPF (Stimulator, Muscle, Powered, 14); IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat, 13); IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, 8).
Has Chattanooga Group, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Chattanooga Group, Inc. Related entities may recall under other names.
Next steps
- See all 81 Chattanooga Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Chattanooga Group, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.