Heat IN A Click: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Heat IN A Click” (first 2018, latest 2020), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 392 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 |
|---|---|---|
| 2018 | 1 | 311 |
| 2019 | 0 | — |
| 2020 | 1 | 473 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Heat IN A Click took a median 392 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 164 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 1 | 1 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 1 | 1 |
Review panels
Most recent Heat IN A Click 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191940 | Palm NRG cellulite and muscle toning body device | PBX | 2020-11-03 | 473 |
| K171821 | 2 Face / Face Evolution | NFO | 2018-04-26 | 311 |
Recalls
openFDA lists no recalls under a recalling firm named Heat IN A Click.
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.
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.
- Heat IN A Click, LLC (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Heat IN A Click?
FDA lists 2 510(k) clearances under the applicant name “Heat IN A Click” (first 2018, latest 2020), across 2 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 Heat IN A Click?
The median time from FDA receipt to decision across 510(k)s cleared under the name Heat IN A Click is 392 days.
Which FDA product codes appear under Heat IN A Click?
The most frequent FDA product codes under this applicant name are NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes, 1); PBX (Massager, Vacuum, Radio Frequency Induced Heat, 1).
Next steps
- See all 2 Heat IN A Click clearances with predicates and recalls
- Run predicate analysis for product code NFO, Heat IN A Click'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.