Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Heat IN A Click, LLC · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
266 daysmedian FDA review time
406 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253279 | Feather/numiere 05 06 07 (05) | Heat IN A Click, LLC | 2025-12-24 | 86 | 0 |
| K251871 | FEATHER 01 02 03 04 (Model:01) | Heat IN A Click, LLC | 2025-08-15 | 58 | 0 |
| K214015 | Palm NRG cellulite body device (model: Palm NRG body device) | Heat IN A Click, LLC | 2022-09-26 | 278 | 0 |
| K202055 | Looper (Model: ZX-579S) | Heat IN A Click, LLC | 2021-04-16 | 266 | 0 |
| K191938 | FitRelief TENS&EMS Wireless Device | Heat IN A Click, LLC | 2020-08-28 | 406 | 0 |
| K150308 | Palm TENS | Heat IN A Click, LLC | 2015-10-20 | 253 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda