(Total Views: 515)
Posted On: 09/07/2020 4:45:35 PM
Post# of 8399
Scott Specialties, Still in the Ball Game......
Scott Specialties who was supposed to have had an 'ActiPatch Enhanced' Brace product out last year is back. Scott just seemed to fade away in 2019 with no mention of what happened.
Scott now shows up in the current FDA 'Establishment Registration & Device Listing' with two entries. Both entries reference FDA 510k 192234 which is BIEL's 1/31/2020 Full Body Musculoskeletal FDA Clearance. This number did not exist until 1/31/2020.
All companies involved in the production and distribution of medical devices must register in this database. Scott's 'Operations' are stated as "Repackager/Relabeler".
Sounds like Scott may have decided to wait for the larger Market of 'Full Body Musculoskeletal' before moving forward with their Products.
The registration #1933909 can be viewed at this Link, https://www.accessdata.fda.gov/scripts/cdrh/c...p;lpcd=PQY
The registration #1917910 can be viewed at this Link, https://www.accessdata.fda.gov/scripts/cdrh/c...p;lpcd=PQY
Scott Specialties who was supposed to have had an 'ActiPatch Enhanced' Brace product out last year is back. Scott just seemed to fade away in 2019 with no mention of what happened.
Scott now shows up in the current FDA 'Establishment Registration & Device Listing' with two entries. Both entries reference FDA 510k 192234 which is BIEL's 1/31/2020 Full Body Musculoskeletal FDA Clearance. This number did not exist until 1/31/2020.
All companies involved in the production and distribution of medical devices must register in this database. Scott's 'Operations' are stated as "Repackager/Relabeler".
Sounds like Scott may have decided to wait for the larger Market of 'Full Body Musculoskeletal' before moving forward with their Products.
The registration #1933909 can be viewed at this Link, https://www.accessdata.fda.gov/scripts/cdrh/c...p;lpcd=PQY
The registration #1917910 can be viewed at this Link, https://www.accessdata.fda.gov/scripts/cdrh/c...p;lpcd=PQY
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