Pain Management Technologies: FDA filings under this applicant name
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Pain Management Technologies” (first 2001, latest 2022), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 120 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 151 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 259 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pain Management Technologies took a median 259 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXY | Electrode, Cutaneous | 2 | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 | 2 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 | 1 |
| NYN | Stimulator, Electrical, Transcutaneous, For Arthritis | 1 | 1 |
Review panels
- Neurology (5)
- Physical Medicine (1)
Most recent Pain Management Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213097 | Armory Motion | ILO | 2022-06-10 | 259 |
| K120054 | ULTIMA NEO | GZJ | 2012-06-05 | 151 |
| K083494 | ULTIMA FIVE | GZJ | 2009-01-06 | 42 |
| K073386 | JOINT STIM, MODEL 1000 | NYN | 2008-07-30 | 240 |
| K030375 | SOFT-TOUCH TENS ELECTRODE | GXY | 2003-05-05 | 90 |
| K011411 | SELF-ADHESIVE ELECTRODES | GXY | 2001-06-13 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Pain Management Technologies.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Pain Management Technologies (5)
- Pain Management Technologies, Inc. (1)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pain Relief Technologies (3 510(k)s)
- Pain Concepts, Inc. (1 510(k)s)
- Pain Prevention, Inc. (1 510(k)s)
- Pain Prevention Laboratory, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pain Management Technologies?
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Pain Management Technologies” (first 2001, latest 2022), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pain Management Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pain Management Technologies is 120 days.
Which FDA product codes appear under Pain Management Technologies?
The most frequent FDA product codes under this applicant name are GXY (Electrode, Cutaneous, 2); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 2); ILO (Pack, Hot Or Cold, Water Circulating, 1).
Next steps
- See all 6 Pain Management Technologies clearances with predicates and recalls
- Run predicate analysis for product code GXY, Pain Management Technologies's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.