BETA
Developer of a temporary-tattoo and smartphone platform for remote monitoring of orthopedic recovery.
InkWell Health Ltd. is a Canadian medical-technology company founded in 2022. Its company brochure lists Waterloo, Ontario as its Canadian office; its current website lists a U.S. contact office in Troy, Michigan. The platform connects orthopedic patients with clinical teams during recovery.
Its remote therapeutic monitoring system combines a temporary skin tattoo, patient smartphone application and clinician-facing software. The company describes monitoring changes in swelling, range of motion and temperature after knee surgery or injury. Its leadership page identifies internal computer-vision and algorithm-development expertise.
The knee monitoring product is commercially marketed through clinical practices. A company announcement also describes an upcoming Foot & Ankle Tattoo launch; broad availability and U.S. regulatory mapping for that extension remain unconfirmed. Upright Medical Solutions advertises the knee offering.
Device records list an InkWell large left knee temporary tattoo under skin-marker product code FZZ and mark that component exempt from premarket submission. It identifies InkWell Health Ltd as labeler and report commercial distribution. This device-identification record is not FDA clearance of the complete monitoring system. [1]
No matching published 510(k), De Novo grant or PMA was found in the named searches. The precise U.S. regulatory basis for the application, algorithms and combined system remains unresolved. The app listing’s developer-supplied medical-device disclosure and owner/operator number do not resolve that question. [1][2]
The manufacturer IFU describes physician monitoring of qualitative changes in swelling, range of motion and temperature. It warns against applying tattoos to broken skin or unhealed incisions and notes that skin conditions or existing tattoos can impair detection and calculations. A temperature sticker is used for temperature entries; the system is not described here as a standalone diagnostic replacement. [16]
Recovery-monitoring and clinical-workflow descriptions are attributed product claims. Neither an exempt skin-marker record nor RTM billing codes establishes that the system diagnoses infection, prevents complications or guarantees reimbursement. [12][15]
Published FDA searches under the company and selected product names found no relevant original PMA approvals, De Novo grants or recall events. Unrelated name matches are excluded. [8][6][7][9]
Latest recorded source review: 2026-10-27.
Documented commercial product families.
Temporary skin marking used with smartphone images and software to support remote review of swelling, range of motion and temperature during orthopedic recovery. [10][12][15][2][1][16]
Tattoo listed as exempt skin marker; full-system pathway not establishedCommercially marketed to orthopedic and physical-therapy practices in the United States.
A company announcement describes an upcoming Foot & Ankle Tattoo launch and invites clinical launch sites. It is retained as a development signal without an assumed launch date, broad availability or inherited authorization. Current employee vacancies were not verified in reviewed primary sources. [17]
Company-announced extension of the temporary-tattoo and application platform to foot-and-ankle recovery. [17]
Company-announced; availability and FDA mapping unconfirmedCompany describes an upcoming launch and invites launch sites; broad availability remains unconfirmed.
Publicly documented relationships; coverage may be incomplete.
| Partner | Territory / scope | Products |
|---|---|---|
| Upright Medical Solutions (distributor-reported) [5] | U.S. provider-facing offering; product-specific territory and active contract not independently confirmed | InkWell Health knee remote therapeutic monitoring system (IWH-K) |
Sources checked October 26, 2026.
Accessed 10/27/2026
Last substantive review: 10/27/2026